Stretch Valve Balloon Catheter and Methods for Producing and Using Same

ABSTRACT

A method of manufacturing a safety catheter includes providing a catheter having a catheter body comprising an exterior surface, a drainage lumen, and an inflation lumen, forming a balloon inflation port between the exterior surface and the inflation lumen, forming a deflation port between the exterior surface and one of the inflation and drainage lumens, fixing a balloon sleeve to the exterior surface over at least the balloon inflation port to define a fluid-tight balloon interior between an interior surface of the balloon sleeve and at least a portion of the exterior surface, removably inserting a deflation plug in the deflation port to water-tightly seal the deflation port until the deflation plug is removed, connecting a proximal portion of a deflation connector to an inside surface of one of the lumens, and connecting a distal portion of the deflation connector to the deflation plug.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 17/461,829, filed on Aug. 30, 2021, which application:

-   -   is a continuation of U.S. patent application Ser. No.        16/200,068, filed on Nov. 26, 2018, now U.S. Pat. No.        11,103,682, issued on Aug. 31, 2021, which:        -   is a continuation of U.S. patent application Ser. No.            15/474,242, filed on Mar. 30, 2017, now U.S. Pat. No.            10,137,282, issued on Nov. 27, 2018, which:            -   is a continuation of U.S. patent application Ser. No.                14/473,244, filed on Aug. 29, 2014, now U.S. Pat. No.                9,713,698, issued on Jul. 25, 2017, which:                -   is a continuation-in-part of U.S. patent application                    Ser. No. 13/713,205, filed Dec. 13, 2012, now U.S.                    Pat. No. 9,005,165, issued on Apr. 14, 2015;                -   is a continuation-in-part of U.S. patent application                    Ser. No. 13/862,163, filed on Apr. 12, 2013, now                    U.S. Pat. No. 9,056,192, issued on Jun. 16, 2015,                    which:                -    is a continuation-in-part of U.S. patent                    application Ser. No. 13/707,752, filed Dec. 7, 2012,                    now U.S. Pat. No. 8,591,497, issued on Nov. 26,                    2013; and                -    claims the benefit of U.S. Provisional Patent                    Application No. 61/637,690, filed on Apr. 24, 2012;                -   is a continuation-in-part of U.S. patent application                    Ser. No. 13/868,376, filed on Apr. 23, 2013, now                    U.S. Pat. No. 9,586,022, issued Mar. 7, 2017, which:                -    is a continuation-in-part of U.S. patent                    application Ser. No. 13/862,163, filed on Apr. 12,                    2013, now U.S. Pat. No. 9,056,192, issued Jun. 16,                    2015;                -    is a continuation-in-part of U.S. patent                    application Ser. No. 13/707,752, filed on Dec. 7,                    2012, now U.S. Pat. No. 8,591,497, issued Nov. 26,                    2013; and                -    claims the benefit of U.S. Provisional Patent                    Application No. 61/637,690, filed on Apr. 24, 2012;                -   is a continuation-in-part of U.S. patent application                    Ser. No. 14/024,151, filed on Sep. 11, 2013, now                    U.S. Pat. No. 9,272,120, issued Mar. 1, 2016, which:                -    is a divisional of U.S. patent application Ser. No.                    13/707,752, filed on Dec. 7, 2012, now U.S. Pat. No.                    8,591,497, issued Nov. 26, 2013; and                -    is a continuation-in-part of U.S. patent                    application Ser. No. 13/713,205, filed on Dec. 13,                    2012, now U.S. Pat. No. 9,005,165, issued Apr. 14,                    2015;                -   a continuation-in-part of U.S. patent application                    Ser. No. 14/024,440, filed on Sep. 11, 2013, now                    U.S. Pat. No. 9,044,571, issued Jun. 2, 2015, which:                -    is a continuation-in-part of U.S. patent                    application Ser. No. 13/868,376, filed on Apr. 23,                    2013, now U.S. Pat. No. 9,586,022, issued Mar. 7,                    2017;                -    is a continuation-in-part of U.S. patent                    application Ser. No. 13/862,163, filed on Apr. 12,                    2013, now U.S. Pat. No. 9,056,192, issued Jun. 16,                    2015; and                -    is a continuation-in-part of U.S. patent                    application Ser. No. 13/707,752, filed on Dec. 7,                    2012, now U.S. Pat. No. 8,591,497, issued Nov. 26,                    2013, which:                -    claims the benefit of U.S. Provisional Patent                    Application No. 61/637,690, filed on Apr. 24, 2012;                -   is a continuation-in-part of U.S. patent application                    Ser. No. 14/292,112, filed on May 30, 2014, now U.S.                    Pat. No. 9,669,193, issued Jun. 6, 2017, which:                -    is a continuation-in-part of U.S. patent                    application Ser. No. 14/024,440, filed on Sep. 11,                    2013, now U.S. Pat. No. 9,044,571, issued Jun. 2,                    2015;                -    is a continuation-in-part of U.S. patent                    application Ser. No. 14/024,151, filed on Sep. 11,                    2013, now U.S. Pat. No. 9,272,120, issued Mar. 1,                    2016;                -    is a continuation-in-part of U.S. patent                    application Ser. No. 13/868,376, filed on Apr. 23,                    2013, now U.S. Pat. No. 9,586,022, issued Mar. 7,                    2017;                -    is a continuation-in-part of U.S. patent                    application Ser. No. 13/862,163, filed on Apr. 12,                    2013, now U.S. Pat. No. 9,056,192, issued Jun. 16,                    2015; and                -    is a continuation-in-part of U.S. patent                    application Ser. No. 13/713,205, filed on Dec. 13,                    2012, now U.S. Pat. No. 9,005,165, issued Apr. 14,                    2015, which:                -    is a divisional of U.S. patent application Ser. No.                    12/943,453, filed on Nov. 10, 2010, now U.S. Pat.                    No. 8,382,708, issued Feb. 26, 2013;            -   is a continuation-in-part of U.S. patent application                Ser. No. 14/981,238, filed on Dec. 28, 2015, now U.S.                Pat. No. 9,878,124, issued Jan. 30, 2018, which:                -   is a continuation of U.S. patent application Ser.                    No. 14/024,151, filed on Sep. 11, 2013, now U.S.                    Pat. No. 9,272,120, issued Mar. 1, 2016, which:                -    is a division of U.S. patent application Ser. No.                    13/707,752, filed on Dec. 7, 2012, now U.S. Pat. No.                    8,591,497, issued Nov. 26, 2013, which:                -    claims the benefit of U.S. Provisional Patent                    Application No. 61/637,690, filed on Apr. 24, 2012;                -    is a continuation-in-part of U.S. patent                    application Ser. No. 13/713,205, filed on Dec. 13,                    2012, now U.S. Pat. No. 9,005,165, issued Apr. 14,                    2015, which:            -   is a continuation-in-part of U.S. patent application                Ser. No. 14/702,273, filed on May 1, 2015, now U.S. Pat.                No. 9,642,992, issued May 9, 2017, which:                -   a continuation-in-part of U.S. patent application                    Ser. No. 14/024,151, filed on Sep. 11, 2013, now                    U.S. Pat. No. 9,272,120, issued Mar. 1, 2016;                -   is a divisional of U.S. patent application Ser. No.                    13/862,163, filed on Apr. 12, 2013, now U.S. Pat.                    No. 9,056,192, issued Jun. 16, 2015;                -    claims the benefit of U.S. Provisional Patent                    Application No. 61/637,690, filed on Apr. 24, 2012;            -   is a continuation-in-part of U.S. patent application                Ser. No. 14/292,112, filed on May 30, 2014, now U.S.                Pat. No. 9,669,193, issued Jun. 6, 2017, which:                -   is a continuation-in-part of U.S. patent application                    Ser. No. 14/024,440, filed on Sep. 11, 2013, now                    U.S. Pat. No. 9,044,571, issued Jun. 2, 2015;                -   is a continuation-in-part of U.S. patent application                    Ser. No. 14/024,151, filed on Sep. 11, 2013, now                    U.S. Pat. No. 9,272,120, issued Mar. 1, 2016;                -   is a continuation-in-part of U.S. patent application                    Ser. No. 13/868,376, filed on Apr. 23, 2013, now                    U.S. Pat. No. 9,586,022, issued Mar. 7, 2017;                -   is a continuation-in-part of U.S. patent application                    Ser. No. 13/862,163, filed on Apr. 12, 2013, now                    U.S. Pat. No. 9,056,192, issued Jun. 16, 2015;                -   is a continuation-in-part of U.S. patent application                    Ser. No. 13/713,205, filed on Dec. 13, 2012, now                    U.S. Pat. No. 9,005,165, issued Apr. 14, 2015,                    which:                -    a divisional of U.S. patent application Ser. No.                    12/943,453, filed on Nov. 10, 2010, now U.S. Pat.                    No. 8,382,708, issued Feb. 26, 2013,                    the prior applications are hereby incorporated                    herein by reference in their entirety.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates to a catheter, especially an automaticallydeflating balloon catheter with a stretch valve and methods for usingand manufacturing such a catheter.

Description of Related Prior Art

A number of conventional balloon catheters exist in the prior art. Somecatheters are used to drain the bladder of a patient during surgicalprocedure or to treat bladder and/or urethra or prostate conditions, forexample. Other catheters are used to occlude a lumen, such as a bloodvessel, for various reasons (e.g., isolation, angioplasty,valvuloplasty), to pull a thrombus out of a blood vessel, or to dilatesstrictures. Further catheters are used to provide assistance withbreathing, such as endotracheal tubes. One example is a common ballooncatheter referred to as a Foley catheter, which is widely used today fortreating and draining a patient's bladder. The Foley catheter is shownin FIG. 1 and has a multi-lumen shaft 1 that is disposed in the urethra10, a balloon portion 3 disposed at the distal end of the shaft 1, afluid drain section 4 disposed at the distal end of the balloon 3, and acurved or straight, distal guiding tip 5 at the distal-most end of theentire catheter. When placed properly, the proximal-most side of theinflated balloon 3 rests on the interior wall 31 of the bladder 30,entirely blocking off the bladder-urethral junction 11 connecting thebladder 30 and the urethra 10. In such a position, the fluid drainsection 4 allows continuous drainage of the bladder 30 and the balloon 3virtually prevents the catheter from slipping out of the bladder. Thisideally inserted position is shown in FIG. 1 . As used herein, a fluidcan be either a liquid or a gas. Exemplary fluids for inflating aballoon 3 are saline, sterile water, air, or carbon dioxide gas.Exemplary fluids drained by the catheters mentioned herein include urineand blood.

Basically, the balloon catheter has a tube-like body with two lumenspassing therethrough. The larger lumen is open to the treatment locationfor drainage of the fluid (e.g., urine in the bladder) distally orupstream and empties into a non-illustrated ex-corporeal bag (proximallyor downstream) for eventual disposal. A smaller lumen is used to inflate(and deflate) the balloon 3 with sterile water (typically) using asyringe attached to the inflation lumen fitting 260 (see, e.g., FIG. 3). When inflated in the bladder, for example, the catheter issubstantially prevented from sliding out of the urethra in use.

A conventional balloon 3 has a substantially constant balloon wallthickness. The balloon 3 is fixed to the outer surface of a fluiddrainage line (not illustrated in FIG. 1 ) and is not intended to beremoved therefrom or to burst thereon unless an extraordinary amount ofinflation occurs. If such an event happens, the material of the balloonwill open at a random location based upon the microscopic fractures orweaknesses in the material itself. Such a tearing event is not supposedto occur under any circumstances during use with a patient.

Prior art urinary catheters are not constructed to prevent tearing ofthe urethra during a catheter implanting procedure and are notconstructed to break in any predefined way. Prior art catheters aredesigned to deflate only when actively deflated, either by a syringesimilar to the one that inflated it or by surgery after the physiciandiagnoses the balloon as not being able to deflate, in whichcircumstance, a procedure to pop the balloon surgically is required.

Over 96 million indwelling catheters are sold worldwide on an annualbasis. Twenty four million catheters are sold to hospitals in the U.S.There are numerous complications associated with those catheters thatneed to be prevented. These complications are responsible for increasesin hospital stays, excessive bleeding, mortality, as well as morbidity.They also cause an increased expense and burden on the already-stressedhealth care system.

The complications result from several different mechanisms. First, andprobably most common, is improper placement of the catheter. Because ofthe unique anatomy of the male urethra, placing a urethral catheter forurinary drainage can be difficult. A problem arises when the physician,technician, or nurse thinks that the catheter is actually in a properposition when it is not. The proper position for the catheter is withthe balloon located in the cavity of the bladder. In this position, thetip distal to the balloon is located in the bladder and is used to drainthe bladder cavity of urine.

For placement of this catheter in the bladder 30 in the ideal position,however, the physician or technician has no visual aid. As shown in FIG.1 , the wall 40 defining the bladder-urethral junction 11 is very shortin the longitudinal direction of the urethra 10. If the physicianinserts the catheter too far into the bladder 30, no damage occurs fromballoon inflation; however, there is a possibility of leakage around theballoon 3, which, under normal conditions, actually helps to lubricatethe urethra 10. In such a case, gentle proximal movement of the shaft 1will place the proximal side of the balloon 3 against thebladder-urethral junction 11. The bladder 30 can then easily expand andstretch to compensate for the balloon 3. A normal bladder capacity is400 cc to 500 cc. A normal balloon capacity is approximately 10 cc to 12cc although larger balloons are sometimes used. A typical balloon is 5cc, however, most clinicians put 10 cc of water in the balloon forinflation. With 5 cc of water in the balloon, the diameter isapproximately 2 cm and with 10 cc the diameter is approximately 2.5 cm.

Complications occur when the technician and/or nurse inflates theballoon when the balloon is not in the bladder. If the technician doesnot insert the catheter in far enough, then the balloon 3 will beinflated within the urethra 10—a condition that, while common, is to beavoided at all costs and is a frequent cause of bladder infectionscreated during a hospital or clinic visit. Infections arise becauseinflation of the bladder 3 inside the urethra 10 causes the urethra 10to stretch too far and tear. Even though the urethra 10 is a flexibletube, it has limits to which it can be safely stretched from within.Almost every balloon catheter has a balloon outer diameter/circumferencethat well-exceeds the safe stretching limit of the urethra 10.Therefore, if the balloon catheter is not inserted far enough, inflationof the balloon 3 will cause serious injury to the urethra 10. This isespecially true with elderly patients who have urethras that are not aselastic as younger patients. Also, just as important is the change inanatomy of older males, in particular, the prostatic portion of theurethra. With age, the prostate becomes larger and, sometimes, thecatheter cannot be advanced through the prostatic portion of theurethra. When this occurs, the technician does not insert the catheterall the way into the bladder and inflates the balloon within theurethra. Alternatively, strictures, i.e., scar tissue, cause thecatheter to halt and further pressure tears the urethral wall to createa new, unintended passage. Both of these improper insertions causesevere bleeding and damage.

The elastomeric balloon of present-day catheter products requiresrelatively high pressures to initiate inflation and expand to anexpected full-diameter shape upon over-inflation. As such, whenincorrectly placed in the urethra, the rapid inflation, combined withthe high-pressure, causes the balloon to tear the surrounding membrane,referred to as the mucosa. Tearing of the urethra 10 in this way causesbleeding and allows bacteria to enter into the bloodstream at the tearsite, thus causing the subsequent bladder infection and, eventually,sepsis. Significant bleeding can become life threatening. The urethracan normally dilate several millimeters; however, when the balloon isinflated, this dilation is usually several centimeters. Also, withoutsufficient and immediate venting of the balloon inflation fluid afterimproper placement, an accidental or intentional pull on the catheterexternally can and does cause extensive bodily harm to the patient.

Life threatening bleeds, especially in patients who are anticoagulated,can and do occur. Also, when the urine is infected, as inimmunocompromised patients and the elderly, the bacteria enter the bloodstream and can cause serious infections (e.g., sepsis), which frequentlycan lead to death. If the patient survives the initial trauma, thenlong-term complications, such as strictures, can and usually do occur.Strictures cause narrowings within the urine channel and usually requireadditional procedures and surgeries to correct.

Other mechanisms of catheter-induced injuries are inadvertentmanipulation of the tubing or dislodging of the balloon—caused when thecatheter is pulled from outside the patient due to a sudden jerk ortension. This commonly happens when the patient is ambulating ortraveling from the bed to the commode or bathroom. The tubing mayinadvertently become fixed while the patient is still moving, at whichtime a sudden jerk is imparted upon the balloon and pulls the ballooninto the urethra, which tears the urethra, causing severe pain andbleeding. Injury caused by the improper, inadvertent, and/or earlyremoval of an inflated balloon catheter is referred to as iatrogenicinjury (also referred to as an in-hospital injury). Hundreds ofthousands of such iatrogenic injuries occur each year—all of which needto be prevented, not only for patient safety, but also because the costimposed on the medical health industry for each injury is enormous.

Yet another scenario occurs when the patient deliberately pulls on thecatheter, thereby causing self-induced pain and injury to the urethra.This commonly happens in confused patients, for example, patients innursing homes who have a disease or cognitive dysfunction problem, suchas Alzheimer's disease, or other diseases that make the patient unableto understand the necessity of having a catheter. Confusion occurs whenthe patient has a spasm causing pain and a strong urge to urinate.During the spasm, the confused patient often tugs and pulls on acatheter, which results in injury. Like iatrogenic injuries, theseself-induced injuries must be prevented. In the particular case ofinjury caused by catheter withdrawal when the balloon is inflated(either iatrogenic or self-induced), hospitals have categorized suchinjuries as “never events”—occurrences that should never happen. Undersuch circumstances, insurance typically does not cover the resultingextensive medical expenses.

The injuries mentioned herein are not limited to males and also causesevere damage to the female bladder and urethra. The injuries can alsooccur post-surgically, which makes the damage even more severe. Onecommon situation where injury is caused is when the patient is medicatedwith morphine or other analgesics that render the patient confused andunable to make rational decisions. Feeling the foreign body inside theurethra, the confused patient does not know to leave it alone and,instead, gives it the injury-causing tug. These injuries have beenwell-documented and are not limited to adults. Numerous injuries aredocumented in pediatric patients.

Usually, it takes time to make a diagnosis of patient-caused catheterinjury. Immediately after diagnosing the injury, a technician needs todeflate the catheter. However, once the urethra is torn, replacing thedamaged catheter with another catheter is quite difficult and, in fact,exacerbates the injury. Sometimes, the patient has to be taken to theoperating room to replace a urinary drainage tube once the injuryoccurs. Because catheters and leg bags are now used routinely in certainsituations during home health care, this scenario is not limited tohospitals and occurs at nursing homes and patients' homes as well.

Most of the recent catheter technology has been focused on reducingurinary tract infections that are caused by catheters, injuries that areusually the most common catheter-related complications. One example ofsuch technology is impregnation of the catheter with antimicrobials orantibiotics. But, these advances do nothing to prevent the injuriesexplained herein.

With regard to balloon catheters other than urinary catheters, such asendotracheal tubes, tracheostomy tubes, fogarty-type atherectomy ballooncatheters, isolation catheters, angioplasty balloon catheters,valvuloplasty catheters, vertebroplasty balloons, and other balloonsthat dilate lumens, none are provided with any self-regulating orself-deflating safety features.

Accordingly, it would be beneficial to provide a balloon catheter thatdoes not inflate past the tearing limit of a lumen (e.g., a urethra) anddeflates in a desired, predefined way under certain conditions.

SUMMARY OF THE INVENTION

It is accordingly a desire to provide an automatically deflatingpressure balloon catheter with a stretch valve and methods formanufacturing and using the catheter that overcome thehereinafore-mentioned disadvantages of the heretofore-known devices andmethods of this general type and quickly and rapidly deflates if pulledout prior to physician-scheduled deflation of the balloon or thatdeflates partially if over-inflated.

With the foregoing and other objects in view, there is provided, inaccordance with the invention, a safety balloon catheter including aflexible, multi-lumen balloon catheter having a proximal catheter end, aballoon defining a balloon interior to be inflated with an inflationfluid, a hollow inflation lumen extending through the catheter to theballoon interior and shaped to convey the inflation fluid to and fromthe balloon interior, a hollow second lumen parallel to the inflationlumen, and a balloon drainage port fluidically connecting the ballooninterior to the second lumen, a stretch valve having a hollow base fixedin the second lumen adjacent the proximal catheter end and shaped topermit a fluid to pass therethrough and a hollow plug shaped to permit afluid to pass therethrough and slidably positioned in the second lumenat a given distance from the base to, in a steady state, prevent theinflation fluid from passing through the drainage port and, in anactuated state, slide within the second lumen to permit the inflationfluid to pass through the drainage port and into the second lumen, and aconnector connected to the base and to the plug and having a lengthequal to or greater than the given distance between the hollow plug andthe base.

With the objects of the invention in view, there is also provided asafety urinary catheter including a flexible, multi-lumen ballooncatheter having a proximal catheter end, a balloon having a proximalballoon end and defining a balloon interior to be inflated with aninflation fluid, a hollow inflation lumen extending through the catheterto the balloon interior and shaped to convey the inflation fluid to andfrom the balloon interior, a hollow drain lumen parallel to theinflation lumen, and a balloon drainage port fluidically connecting theballoon interior to the drain lumen, and a stretch valve having a hollowbase fixed in the drain lumen adjacent the proximal catheter end andshaped to permit a fluid to pass therethrough and a hollow plug shapedto permit a fluid to pass therethrough and slidably positioned in thedrain lumen at a given distance from the base to, in a steady state,prevent the inflation fluid from passing through the drainage port and,in a stretched state when a length between the proximal catheter end andthe proximal balloon end is elongated between approximately 5 percentand approximately 200 percent, the plug slides within the drain lumen topermit the inflation fluid to pass through the drainage port and intothe drain lumen, and a connector connected to the base and to the plugand having a length greater than the given distance. The balloondrainage port has an axis perpendicular to the longitudinal axis of thecatheter.

With the objects of the invention in view, there is also provided asafety urinary catheter including a safety urinary catheter including astretch valve, a connector, and a flexible, multi-lumen ballooncatheter. The flexible, multi-lumen balloon catheter has a proximalcatheter end, a balloon having proximal and distal balloon ends anddefining a balloon interior to be inflated with an inflation fluid, ahollow inflation lumen extending through the catheter to the ballooninterior and shaped to convey the inflation fluid to and from theballoon interior, a hollow drain lumen parallel to the inflation lumen,and a balloon drainage port fluidically connecting the balloon interiorto the drain lumen. The stretch valve has a base fixed in one of theinflation lumen and the drain lumen adjacent the proximal catheter endat a given distance from the balloon drainage port and shaped to permita fluid to pass thereby, a plug shaped to block the balloon drainageport when installed therewithin and prevent fluid from passing throughthe balloon drainage port, and a connector connected to the base and tothe plug and having a length greater than the given distance. When theplug is installed in the balloon drainage port, the plug prevents theinflation fluid from passing through the balloon drainage port and, in astretched state when a length between the proximal catheter end and theproximal balloon end is elongated between approximately 5 percent andapproximately 200 percent, the plug exits the balloon drainage port topermit the inflation fluid to pass therethrough into the drain lumen.

In accordance with another feature of the invention, the connector isinelastic or partially elastic and partially inelastic. The partiallyelastic portion of the connector can be a spring.

In accordance with an additional feature of the invention, the inflationlumen is fluidically connected to the balloon interior through at leastone inflation port.

In accordance with yet an added feature of the invention, the balloondrainage port is a plurality of balloon drainage ports each fluidicallyconnecting the balloon interior to the second lumen.

In accordance with yet an additional feature of the invention, theplurality of balloon drainage ports each fluidically connect at leastone of the balloon interior and the inflation lumen to the second lumenand the stretch valve, in the steady state, positions the plug in thesecond lumen to prevent fluid from passing through the plurality ofballoon drainage ports and, in the actuated state, the plug slideswithin the second lumen to permit the inflation fluid to pass throughthe plurality of balloon drainage ports.

In accordance with again another feature of the invention, the balloonhas a balloon proximal end, the balloon catheter further comprises astretch portion between the proximal catheter end and the balloonproximal end, and the actuated state of the stretch valve is a stretchedstate of the stretch portion at a pull force of between approximately 1pound and approximately 15 pounds applied to the proximal shaft portion.

In accordance with another feature of the invention, the balloon has aballoon proximal end, the balloon catheter further comprises a stretchportion between the proximal catheter end and the balloon proximal end,and the actuated state of the stretch valve is a stretched state of thestretch portion at a pull force of between approximately 1 pound andapproximately 5 pounds applied to the proximal shaft portion.

In accordance with yet another feature of the invention, the balloon hasa balloon proximal end, the balloon catheter further comprises a stretchportion between the proximal catheter end and the balloon proximal end,and the actuated state of the stretch valve is a stretched state of thestretch portion at a pull force of between approximately 1.5 pounds andapproximately 2 pounds applied to the proximal shaft portion.

In accordance with yet a further feature of the invention, when theballoon portion is inflated with a fluid and a pull force of greaterthan approximately 15 pounds is applied to the stretch portion, thestretch valve meets the stretched state and thereby deflates theinflated hollow balloon portion.

In accordance with yet an added feature of the invention, when theballoon portion is inflated with a fluid and a pull force of greaterthan approximately 5 pounds is applied to the stretch portion, thestretch valve meets the stretched state and thereby deflates theinflated hollow balloon portion.

In accordance with yet an additional feature of the invention, when theballoon portion is inflated with a fluid and a pull force of greaterthan approximately 2 pounds is applied to the stretch portion, thestretch valve meets the stretched state and thereby deflates theinflated hollow balloon portion.

In accordance with again another feature of the invention, the base isfixed in the inflation lumen adjacent the proximal catheter end and,when the plug is installed in the balloon drainage port, the plugprevents the inflation fluid from passing through the balloon drainageport and, in a stretched state when a length between the proximalcatheter end and the proximal balloon end is elongated betweenapproximately 5 percent and approximately 200 percent, the plug exitsthe balloon drainage port into the inflation lumen to permit theinflation fluid to pass through the balloon drainage port into the drainlumen.

In accordance with a concomitant feature of the invention, the base isfixed in the drain lumen adjacent the proximal catheter end and, whenthe plug is installed in the balloon drainage port, the plug preventsthe inflation fluid from passing through the balloon drainage port and,in a stretched state when a length between the proximal catheter end andthe proximal balloon end is elongated between approximately 5 percentand approximately 200 percent, the plug exits the balloon drainage portinto the drain lumen to permit the inflation fluid to pass through theballoon drainage port into the drain lumen.

The low-pressure balloon catheter of the present invention preventsinjury by having the balloon automatically deflate before an injury canoccur, for example, when being forced to withdraw from the bladder orbeing forced to inflate within a urethra.

The stretch valve balloon catheter of the present invention preventsinjury to patients in various ways. First, the stretch valve ballooncatheter of the present invention prevents injury to patients by havingthe balloon automatically deflate before an injury can occur, forexample, when being forced to withdraw from the bladder prior tophysician-scheduled manual deflation. Second, the stretch valve ballooncatheter of the present invention prevents injury to patients bypreventing the balloon from inflating, for example, when being forced toinflate anywhere outside the desired location (e.g., the trachea or theurethra). In the example of a urinary drainage catheter, the stretchvalve balloon catheter of the present invention does not dangerouslyinflate when outside the bladder, such as when in the urethra. Third,the stretch valve balloon catheter of the present invention preventsinjury to the catheter and patient by having the balloon automaticallypartially deflate when overinflated, for example, when a 10 cc balloonis being inflated with 30 cc.

For placement of this catheter in the bladder in the ideal position, anexemplary embodiment described herein provides the physician ortechnician with a visual aid. In particular, markings visible from theoutside of the catheter are placed to indicate average or known lengthsof the lumen in which it is to be placed (e.g., the urethra) and theycan be different depending on the sex, weight, or height of the patient.

While the catheters of the present invention make it a safer device,e.g., for urinary drainage, the present invention can also be used forany procedures in which balloons are used to occlude or distend cavitiesor lumens. Examples of these procedures include coronary artery vesselsand peripheral vascular vessels, such as the aorta and extremityvessels. Balloon dilations of other lumens, such as ureters, bowel,heart valve annulus, prostate and the esophagus, are also candidates foruse of the catheter of the present invention. Further, the mechanism ofpressure release can be used for any fluid or air-filled device such astissue expanders, percutaneous devices, and the like. The inventiveaspects described herein are applicable to all of the various ballooncatheter examples mentioned herein.

Some of the embodiments of the inventive concepts described hereinutilize a valve (e.g., a slit valve or a stretch valve) that permitsreuse when utilized. Although, when a urinary catheter is pulled out bya patient, for example, that catheter is typically discarded forsanitary reasons as exposure outside the treatment area places thecatheter in contact with bacteria that can be introduced to the patientif reuse occurs. With embodiments having non-resetting valves, theinventive balloon catheters are single use after deflation occurs.Although deflation of such a single-use catheter renders it useless, theact of immediate deflation protects the patient from serious harm andthe cost of replacing a catheter is minimal as compared to thesignificant cost of treating catheter-induced injury. Prevention of suchinjuries is becoming more and more important because the injuries arecommonplace. The increase occurs for a number of reasons. First, agreater percentage of the population is aging. Second, there is acurrent trend to use less-skilled health care personnel to perform moreprocedures and to be responsible for treatment, both of which save thehospitals and doctors money. The shortage of nursing professionals(e.g., R.N.s) exacerbates this trend. The present tendency is to usenursing professionals for more functions, such as administration anddelivery of medications. This leaves only the least-skilled technicianswith the task of taking vital signs and inserting catheters. Under suchcircumstances, more injuries are likely and do, in fact, occur. Lastly,catheter-related complications are becoming more severe due to theincreased use of anticoagulation medication, such as PLAVIX®, that isfrequently prescribed in treating cardiovascular disease.

Yet another possible complication arising from the standard Foleycatheter is that the balloon will not deflate even when the deflationmechanism is activated. This situation can occur, for example, becausethe wrong fluid is used to inflate the balloon or when a fluid, such assaline, crystallizes, which happens occasionally. Sometimes, the abilityto deflate the balloon is interrupted because the drainage channel usedto deflate the balloon becomes obstructed, which is common if thecatheter is left in place too long. Remedy of such a scenario involvesan invasive procedure, which includes threading a needle or other sharpobject somewhere through the body cavity to puncture the balloon and,thus, dislodge the catheter. This procedure is not desirable and is tobe avoided if possible. Yet another possible complication can occur whenthe patient has a stricture, i.e., scar tissue in the urethra thatimpedes the passage of the catheter. When a technician is faced with astricture, it seems to the technician that the catheter is no longermoving towards the bladder. Consequently, the technician uses excessiveforce to push the catheter into the bladder, thereby causing a tear thatcreates its own lumen into the penile and prostatic tissue. As isself-evident, this situation is accompanied by significant bleeding andthe need for additional corrective procedures and surgery.

The valved, auto-deflating inventive balloons described herein furtherprovide a self-regulating feature that prevents over-inflation of theballoon. Additionally, the valved, auto-deflating balloons preventinflation when the balloon is not placed in an area large enough forcomplete expansion, e.g., when the balloon of a urinary Foley catheteris inflated within a urethra or the balloon of an endotracheal tube isinflated within a trachea.

With the low-pressure or valved, auto-deflating balloons describedherein, the technician, nurse, or doctor merely needs to pull on thecatheter to cause the catheter to automatically deflate, thus sparingthe patient from any additional surgical procedures.

Added benefits of the catheters described herein do not deal only withsafety, significant financial benefits arise as well. It is understoodthat catheter-induced injuries are much more common than publicdocumentation suggests. Catheter-related trauma occurs no less that oncea week in a large metropolitan hospital. Usually, each incident not onlyincreases the patient's hospital stay substantially, but also theexpense of the stay. Each incident (which is usually not reimbursed byinsurance) can increase the cost to the hospital by thousands ofdollars, even tens or hundreds of thousands of dollars. This isespecially true when the patient brings a personal injury action againstthe hospital, physician(s), and/or staff. And, when additional surgeryis required to repair the catheter-induced injury, increased expense tothe hospital is not only substantial, if litigation occurs as a resultof the injury, damages awarded to the patient can run into the millionsof dollars. In situations where a safety catheter, such as the onesdescribed herein, are available but the hospital or physician decidesnot to use it and, instead, uses a standard catheter, the chance thatpunitive damages are awarded in litigation increases exponentially. Thecatheters and methods described herein, therefore, provide safercatheters that have the possibility of saving the medical industrybillions of dollars.

To prevent urethra tearing occurrences due to premature-improperinflation of the balloon and/or due to premature removal of an inflatedballoon, an exemplary embodiment provides various balloon safety valves.Such valves are configured to release the inflation liquid from theballoon before injury occurs.

The maximum stress that a typical urethra can take without tearingand/or breaking is known and is referred to as a maximum urethrapressure. It is also possible to calculate how much pressure is exertedupon the exterior of a balloon of a balloon catheter by measuring thepressure required to inflate the balloon. Knowing these two values, itis possible to construct a balloon that breaks rapidly and/or ceasesinflation if the maximum urethra pressure is exceeded.

For example, in a first exemplary embodiment, the balloon, which istypically some kind of rubber, silicone, elastomer, or plastic, can bemade with a breaking point that instantly deflates the balloon if thepressure in the balloon exceeds the maximum urethra pressure. It isacknowledged and accepted that, once the balloon breaks, this catheteris useless and must be discarded because the cost of patient injury faroutweighs the cost of the disposable catheter. Also, such a balloon islimited to inflation with a bio-safe fluid to prevent unwanted air/gasfrom entering the patient. If, however, air or other gas will not injurethe patient, the fluid can be air or another gas.

As an alternative to a one-use breaking safety valve, a multi-usepressure valve can be added to the balloon inflation lumen and can beset to open into the drainage lumen if the maximum urethra pressure isexceeded in the balloon or the balloon inflation lumen. Such a valve canbe located near or at the balloon inflation port, for example. Anycombination of the above embodiments is envisioned as well.

Another exemplary embodiment of the present invention provides thecatheter with a balloon that inflates with virtually no pressure. Asused herein, “virtually no pressure,” “zero-pressure” and “low-pressure”are used interchangeably and are defined as a range of pressure betweenapproximately standard atmospheric pressure and 0.3 atmospheres (5psig). This is in contrast to “high-pressure,” which is greater thanapproximately 1.5 atmospheres (22 psig). With such a configuration, thezero-pressure balloon can be deflated with virtually no force. As such,when the clinician attempts to inflate the zero-pressure balloon of thepresent invention within a urethra, the balloon simply does not inflate.Likewise, when the already inflated balloon within the bladder is forcedinto the urethra, such deflation needs virtually no pressure to collapsethe balloon to fit into the urethra. In both circumstances, injury tothe urethra is entirely prevented.

Further exemplary embodiments that prevent urethra tearing occurrencesdue to premature removal of an inflated balloon or inflation outside thetreatment area provide a balloon catheter with a stretch valve andmethods for manufacturing and using such a valved catheter. In thesevariations, the invention takes advantage of the fact that prematureremoval of the inflated balloon catheter requires stretching of thecatheter at the proximal side of the balloon. The valved catheter can beconfigured with a release mechanism that is a function of elongation.With short elongations, the balloon remains inflated. However, whenpulled beyond a preset limit, the valve automatically opens and drainsthe fluid filling the balloon. The existence of the stretch valve alsoprovides the ability to control and eliminate over-inflation. When theballoon is over-inflated, the ends of the balloon (distal and proximal)move away from each other. As this movement occurs, the stretch valvebegins to actuate, thereby deflating the balloon until the proximal anddistal ends no longer stretch the balloon. When these ends are no longerstretched, the valve closes automatically, thereby preventing furtherdeflation of the previously over-inflated balloon. The existence of thestretch valve also provides the ability to control and eliminateinflation when constricted. For example, when the balloon of thestretch-valve safety catheter is attempted to be inflated within theconfines of a urethra, in addition to stretching in the radialdirection, the balloon also stretches in the longitudinal direction—thesame direction as the actuation axis of the stretch valve. Thisstretching causes the stretch valve to open prior to causing significantdamage to the lumen in which the balloon is being inflated (e.g., theurethra), thereby directing the inflation fluid into the drain lumeninstead of the balloon.

In all standard uses of a balloon catheter, the inflation fluid remainsin a closed system. When inflated, the inflation fluid only enters theinflation lumen and the interior of the balloon. When so inflated, theinflation fluid never exits the inflation lumen or the balloon until thehealth professional or user specifically deflates the balloon, typicallywith a syringe similar to the one that was used to the inflate theballoon in the first place. The various balloon catheters describedherein, however, do not possess a closed, balloon-inflation system. Forthe described low-pressure catheter, the inflation fluid is permitted toexit out the proximal and/or the distal ends of the balloon into theenvironment outside the balloon. For the herein-described catheters withslit, stretch, or other internal valves, the inflation fluid ispermitted to exit into the drainage lumen, which is fluidicallyconnected to the external drainage bag and to the drainage opening atthe distal tip of the catheter and, thereby, the bladder or otherexpanse in the body. Likewise, for the herein-described catheters withstretch valves, the inflation fluid is permitted to exit into thedrainage (or inflation) lumen.

It is known that a technician/physician/user inserting a ballooncatheter does not know where the balloon is placed within the body afterthe balloon is inserted therein. It is also known that approximately 25%of patients who are admitted to a hospital will have an indwellingcatheter at some point during their stay and 7% of nursing homeresidents are continually managed by long term catheterization. Over4,000,000 indwelling urinary balloon catheters are inserted in U.S.patients every year and over 25,000,000 are sold in the U.S. every year.Only with radiographic or sonographic equipment can the balloon portionof the catheter be visualized within the body. This type ofvisualization is simply too expensive to use every time, for example, aurinary catheter is used.

The difference from standard closed-system balloon catheters of theherein-described safety catheters provides unique benefits not foundelsewhere or before. More specifically, only with the inventive safetycatheters described herein does the inflation fluid have the opportunityto exit the balloon. When the inflation fluid exits the balloon of thesesafety catheters, it provides a unique and automatic way of informingthe user or health-care professional that a dangerous condition has justbeen prevented. More specifically, if the inflation fluid contains aninert colorant that is different from any color of fluid that typicallyis drained by the balloon catheter, the herein-described safetycatheters will show, visually and immediately, either that an attempthas been made to inflate the balloon within a constricted lumen (such asthe urethra) or that the catheter has been stretched enough to cause thestretch-valve of the inserted balloon to act and prevent possiblepull-out injury. In the former case, if the balloon is attempted to beinflated within a constricted lumen (e.g., urethra) and not in thelarger treatment area (e.g., bladder), then the inflation fluid will,upon the attempted inflation, be almost immediately apparent to theuser/health-care professional when it drains directly into the drainagebag. When the user/health-care professional sees the color in thedrainage bag, he/she knows that the balloon is not correctly placed andcorrective action can be taken immediately and before injury or furtherinjury occurs. In the latter case, if the catheter is pulled by thepatient or by catching the environment, and the catheter is notcompletely removed from the patient, at least some or all of theinflation fluid will drain into the drainage bag. When that bag is nextinspected by the user/health-care professional, it will be immediatelyapparent that something is wrong and that the catheter needs examinationand/or removal and replacement. Some variations herein allow the balloonto even be refilled if deflation occurs without any injury and if thecatheter is not pulled out sufficiently far to require replacement. Inany case, injury is prevented.

The invention is not limited to this visual aid for indicating to aphysician, nurse, or technician that the catheter has been installedimproperly. For male and female patients, it is known approximately howfar the catheter needs to be inserted into the urethra because averageurethra lengths for males and females are known. With this information,the catheter described herein can be provided with external markingsindicating those average urethra lengths. Even if the catheters are notmale or female specific, both indications can be provided on a givencatheter. In this way, if, after believing that insertion is “correct,”the user still sees the marking outside the patient, the user can doublecheck the insertion before inflating the balloon (which would occurwithin the urethra if not installed far enough therein). Additionally,these markings can provide immediate visual indications to medicalpersonnel when it is not known that a patient has jerked out thecatheter partially or the catheter snagged on the environment and waspulled out partially. In either situation, if the medical personnellooks at the catheter and sees the markings, then it becomes immediatelyclear that the inflated balloon catheter has been improperly removed,but partially, and immediate corrective action can be taken.

Description of one exemplary embodiment herein in a way that separatefrom other exemplary embodiments is not to be construed mean that theone embodiment mutually exclusive of the other exemplary embodiments.The various exemplary embodiments of the safety catheters mentionedherein can be used separately and individually or they can be usedtogether in any combination.

Although some variations are illustrated and described herein asembodied in a stretch valve balloon catheter and methods for producingand using such a catheter, they are, nevertheless, not intended to belimited to the details shown because various modifications andstructural changes may be made therein without departing from the spiritof the invention and within the scope and range of equivalents of theclaims. Additionally, well-known elements of exemplary embodiments ofthe invention will not be described in detail or will be omitted so asnot to obscure the relevant details of the invention.

Other features that are considered as characteristic for the inventionare set forth in the appended claims. As required, detailed embodimentsof the present invention are disclosed herein; however, it is to beunderstood that the disclosed embodiments are merely exemplary of theinvention, which can be embodied in various forms. Therefore, specificstructural and functional details disclosed herein are not to beinterpreted as limiting, but merely as a basis for the claims and as arepresentative basis for teaching one of ordinary skill in the art tovariously employ the present invention in virtually any appropriatelydetailed structure. Further, the terms and phrases used herein are notintended to be limiting; but rather, to provide an understandabledescription of the invention. While the specification concludes withclaims defining the features of the invention that are regarded asnovel, it is believed that the invention will be better understood froma consideration of the following description in conjunction with thedrawing figures, in which like reference numerals are carried forward.The figures of the drawings are not drawn to scale.

Before further disclosure and description, it is to be understood thatthe terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting. The terms “a” or“an”, as used herein, are defined as one or more than one. The term“plurality,” as used herein, is defined as two or more than two. Theterm “another,” as used herein, is defined as at least a second or more.The terms “including” and/or “having,” as used herein, are defined ascomprising (i.e., open language). The term “coupled,” as used herein, isdefined as connected, although not necessarily directly, and notnecessarily mechanically.

As used herein, the term “about” or “approximately” applies to allnumeric values, whether or not explicitly indicated. These termsgenerally refer to a range of numbers that one of skill in the art wouldconsider equivalent to the recited values (i.e., having the samefunction or result). In many instances these terms may include numbersthat are rounded to the nearest significant figure. In this document,the term “longitudinal” should be understood to mean in a directioncorresponding to an elongated direction of the catheter. Lastly, theterm “proximal” refers to the end of the catheter closest to the personinserting the catheter and is usually that end of the catheter with ahub. The distal end of the catheter is the end furthest away from theperson inserting the catheter.

BRIEF DESCRIPTION OF THE DRAWINGS

In the following, the invention will be described in more detail byexemplary embodiments and the corresponding figures. By schematicillustrations that are not true to scale, the figures show differentexemplary embodiments of the invention.

FIG. 1 is a diagrammatic, fragmentary, longitudinal cross-sectional viewof a prior art catheter ideally placed in a urethra and a bladder of amale patient;

FIG. 2 is a fragmentary, enlarged, longitudinal cross-sectional view ofa distal portion of a first embodiment of a pressure-limiting ballooncatheter according to the invention;

FIG. 3 is a fragmentary, enlarged longitudinal cross-sectional view of aproximal portion of a second embodiment of a pressure-limiting ballooncatheter according to the invention;

FIG. 4 is a fragmentary, enlarged, cross-sectional view of a firstalternative configuration of the safety valve of FIG. 3 ;

FIG. 5 is a fragmentary, enlarged, cross-sectional view of a secondalternative configuration of the safety valve of FIG. 3 ;

FIG. 6 is a fragmentary, enlarged, cross-sectional view of a thirdalternative configuration of the safety valve of FIG. 3 ;

FIG. 7 is a fragmentary, further enlarged, cross-sectional view of thesafety valve of FIG. 6 ;

FIG. 8 is a fragmentary, further enlarged, cross-sectional view of afourth alternative configuration of the safety valve of FIG. 3 ;

FIG. 9 is a fragmentary, partially hidden, perspective view of anexemplary embodiment of a zero-pressure safety catheter according to theinvention;

FIG. 10 is a radial cross-sectional view of a portion of the catheter ofFIG. 9 at section line 10-10;

FIG. 11 is a process flow diagram of an exemplary method of forming azero-pressure balloon according to the invention;

FIG. 12 is a process flow diagram of an exemplary method of attaching azero-pressure balloon according to the invention;

FIG. 13 is a fragmentary, enlarged, perspective view of a distal portionof an exemplary embodiment of a zero-pressure catheter according to theinvention;

FIG. 14 is a radial cross-sectional view of a slit-valve portion of thecatheter of FIG. 13 at section line 14-14;

FIG. 15 is a radial cross-sectional view of an alternative embodiment ofa slit-valve portion of the catheter of FIG. 13 at section line 15-15;

FIG. 16 is a fragmentary, enlarged, partially cross-sectional andpartially perspective view of an everting balloon catheter according tothe invention in a correctly inserted position in the bladder;

FIG. 17 is a fragmentary, enlarged, partially cross-sectional andpartially perspective view of the catheter of FIG. 16 being pulleddistally out of the bladder and beginning its everting deflation;

FIG. 18 is a fragmentary, enlarged, partially cross-sectional view ofthe catheter of FIG. 16 with the everting deflation complete;

FIG. 19 is a fragmentary, enlarged, longitudinal cross-sectional view ofa balloon portion of a prior art urinary catheter in an uninflatedstate;

FIG. 20 is a fragmentary, enlarged, longitudinal cross-sectional view ofthe prior art urinary catheter of FIG. 19 in an inflated state within abladder;

FIG. 21 is a fragmentary, enlarged, longitudinal cross-sectional view ofa balloon portion of an exemplary embodiment of an automaticallydeflating, stretch valve urinary balloon catheter according to theinvention with the balloon in an uninflated state;

FIG. 22 is a fragmentary, enlarged, longitudinal cross-sectional view ofthe automatically deflating, stretch valve urinary balloon catheter ofFIG. 21 with the balloon in an inflated state and with the stretch valvein an unactuated state;

FIG. 23 is a fragmentary, enlarged, longitudinal cross-sectional view ofthe automatically deflating, stretch valve urinary balloon catheter ofFIG. 21 with the balloon in an inflated state and with the stretch valvein an actuated state;

FIG. 24 is a fragmentary, enlarged, longitudinal cross-sectional view ofa balloon portion of another exemplary embodiment of an automaticallydeflating, stretch valve urinary balloon catheter according to theinvention with the balloon in an uninflated state;

FIG. 25 is a fragmentary, enlarged, longitudinal cross-sectional view ofthe automatically deflating, stretch valve urinary balloon catheter ofFIG. 24 with the balloon in an inflated state and with the stretch valvein an unactuated state;

FIG. 26 is a fragmentary, enlarged, longitudinal cross-sectional view ofthe automatically deflating, stretch valve urinary balloon catheter ofFIG. 24 with the balloon in an inflated state and with the stretch valvein an actuated state;

FIG. 27 is a fragmentary, enlarged, longitudinal cross-sectional view ofa balloon portion of still another exemplary embodiment of anautomatically deflating, stretch valve urinary balloon catheteraccording to the invention with the balloon in an uninflated state;

FIG. 28 is a fragmentary, enlarged, longitudinal cross-sectional view ofthe automatically deflating, stretch valve urinary balloon catheter ofFIG. 27 with the balloon in an inflated state and with the stretch valvein an unactuated state;

FIG. 29 is a fragmentary, enlarged, longitudinal cross-sectional view ofthe automatically deflating, stretch valve urinary balloon catheter ofFIG. 27 with the balloon in an inflated state and with the stretch valvein an actuated state;

FIG. 30 is a fragmentary, enlarged, longitudinal cross-sectional view ofthe automatically deflating, stretch valve urinary balloon catheter ofFIG. 27 ;

FIG. 31 is a fragmentary, enlarged, longitudinal cross-sectional view ofthe automatically deflating, stretch valve urinary balloon catheter ofFIG. 27 turned ninety degrees counterclockwise when viewed from aproximal end thereof and with the stretch valve in an unactuated state;

FIG. 32 is a fragmentary, enlarged, longitudinal cross-sectional view ofthe automatically deflating, stretch valve urinary balloon catheter ofFIG. 27 turned ninety degrees counterclockwise when viewed from aproximal end thereof and with the stretch valve in an actuated state;

FIG. 33 is a fragmentary, enlarged, longitudinal cross-sectional view ofa balloon portion of yet another exemplary embodiment of anautomatically deflating, stretch valve urinary balloon catheteraccording to the invention with the balloon in a partially inflatedstate and the stretch valve in an unactuated state;

FIG. 34 is a fragmentary, enlarged, longitudinal cross-sectional view ofa balloon portion of yet a further exemplary embodiment of anautomatically deflating, stretch valve urinary balloon catheteraccording to the invention with the balloon in a partially inflatedstate and the stretch valve in an unactuated state

FIG. 35 is a fragmentary, enlarged, longitudinal cross-sectional view ofa balloon portion of still a further exemplary embodiment of anautomatically deflating, stretch valve urinary balloon catheteraccording to the invention with the balloon in a partially inflatedstate and the stretch valve in an unactuated state;

FIG. 36 is a fragmentary, enlarged, longitudinal cross-sectional view ofa balloon portion of an additional exemplary embodiment of anautomatically deflating, stretch valve urinary balloon catheteraccording to the invention with the balloon in a partially inflatedstate and the stretch valve in an unactuated state;

FIG. 37 is a fragmentary, enlarged, longitudinal cross-sectional view ofa balloon portion of another exemplary embodiment of an automaticallydeflating, stretch valve urinary balloon catheter according to theinvention with the balloon in a partially inflated state and the stretchvalve in an unactuated state;

FIG. 38 is a fragmentary, enlarged, longitudinal cross-sectional view ofa balloon portion of still another exemplary embodiment of anautomatically deflating, stretch valve urinary balloon catheteraccording to the invention with the balloon in a partially inflatedstate and the stretch valve in an unactuated state;

FIG. 39 is a flow chart of exemplary embodiments of processes for makinga catheter according to the invention;

FIG. 40 is a flow chart of exemplary embodiments of other processes formaking a catheter according to the invention;

FIG. 41 is a flow chart of exemplary embodiments of further processesfor making a catheter according to the invention;

FIG. 42 is a fragmentary, enlarged, longitudinal cross-sectional view ofa balloon portion of another exemplary embodiment of an automaticallydeflating, stretch valve urinary balloon catheter according to theinvention with the balloon in a partially inflated state and the stretchvalve in an unactuated state;

FIG. 43 is a fragmentary, enlarged, longitudinal cross-sectional view ofa balloon portion of still another exemplary embodiment of anautomatically deflating, stretch valve urinary balloon catheteraccording to the invention with the balloon in a partially inflatedstate and a longer stretch valve in an unactuated state;

FIG. 44 is an enlarged, perspective view of an exemplary embodiment of astretch valve for a urinary balloon catheter according to the invention;

FIG. 45 is a fragmentary, enlarged, longitudinal cross-sectional view ofa balloon portion of an automatically deflating, stretch valve urinaryballoon catheter with the stretch valve of FIG. 44 in an unactuatedstate and with the balloon in a partially inflated state;

FIG. 46 is an enlarged, perspective view of another exemplary embodimentof a stretch valve for a urinary balloon catheter according to theinvention;

FIG. 47 is a fragmentary, enlarged, longitudinal cross-sectional view ofa balloon portion of an automatically deflating, stretch valve urinaryballoon catheter with the stretch valve of FIG. 46 in an unactuatedstate and with the balloon in a partially inflated state;

FIG. 48 is a fragmentary, enlarged, longitudinal cross-sectional view ofa stretching portion of an automatically deflating, stretch valveballoon catheter with the proximal end of the stretch-valve tube grippedwithin a drainage lumen;

FIG. 49 is an enlarged, longitudinal cross-sectional view of anexemplary embodiment of a stretch-valve actuation device;

FIG. 50 is an enlarged, longitudinal cross-sectional view of anexemplary embodiment of a stretch-valve device;

FIG. 51 is an enlarged, longitudinal cross-sectional view of thestretch-valve device of FIG. 50 installed within a catheter and in avalve-unactuated state;

FIG. 52 is an enlarged, longitudinal cross-sectional view of thestretch-valve device of FIG. 50 installed within a catheter and in avalve-actuated state;

FIG. 53 is an enlarged, longitudinal cross-sectional view of anexemplary embodiment of a stretch-valve device;

FIG. 54 is an enlarged, longitudinal cross-sectional view of thestretch-valve device installed within a catheter and in avalve-unactuated state;

FIG. 55 is an enlarged, longitudinal cross-sectional view of anexemplary embodiment of a plug of the stretch-valve device of FIGS. 50to 54 ;

FIG. 56 is an enlarged, longitudinal cross-sectional view of anexemplary embodiment of a stretch-valve device installed within acatheter and in a valve-unactuated state;

FIG. 57 is a fragmentary, partially hidden, perspective view of anexemplary embodiment of a stretch-valve device installed within aninflation lumen of a catheter in a valve-unactuated state; and

FIG. 58 is a fragmentary, partially hidden, perspective view of anexemplary embodiment of a stretch-valve device installed within a drainlumen of a catheter in a valve-unactuated state.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

While the specification concludes with claims defining the features ofthe invention that are regarded as novel, it is believed that theinvention will be better understood from a consideration of thefollowing description in conjunction with the drawing figures, in whichlike reference numerals are carried forward.

Herein various embodiment of the present invention are described. Inmany of the different embodiments, features are similar. Therefore, toavoid redundancy, repetitive description of these similar features maynot be made in some circumstances. It shall be understood, however, thatdescription of a first-appearing feature applies to the later describedsimilar feature and each respective description, therefore, is to beincorporated therein without such repetition.

Referring now to the figures of the drawings in detail and first,particularly to FIG. 2 thereof, there is shown a first embodiment of apressure-limiting balloon catheter 100 that does not inflate past thetearing limit of a lumen in which the catheter 100 is placed, forexample, in the urethra.

To prevent occurrences of urethra tearing due to premature-improperinflation of the balloon and/or due to premature removal of an inflatedballoon, the invention of the instant application provides the balloon110 with a balloon safety valve 112. As set forth above, in a balloon 3of a conventional catheter (see reference numerals 1 to 5 in FIG. 1 ),the high-pressure balloon 3 is fixed to the outer surface of the fluiddrainage lumen 120 (not shown in FIG. 1 ) and is not intended to beremoved therefrom or to burst thereon unless an extraordinary amount ofinflation occurs. Such a tearing event is not supposed to occur underany circumstances during use with a patient. If such an event happens,the material of the balloon 3 will open at a random location, based uponthe microscopic fractures or weaknesses in the material itself, and riskserious damage to the patient associated with the bursting, as well as arisk of balloon fragmentation, which could leave one or more pieces ofthe balloon 3 inside the patient after removal of the catheter 1.

In contrast to such conventional devices, the balloon 110 of the presentinvention is created specifically to tear when a predefined pressureexists in or is exerted on the balloon 110. The controlled tear willoccur because the balloon safety valve 112 is present. Conventionalballoons have constant balloon wall thicknesses (before inflation). Incontrast thereto, the balloon safety valve 112 in the first embodimentis a defined reduction in balloon wall thickness. This reduction createsa breaking point or selected breaking points at which the balloon 110 isintended specifically to break when a predefined force exists in or isimparted on the balloon 110. Because the balloon 110 is made of amaterial having a known tearing constant—dependent upon the thicknessthereof (which is determined experimentally for different thicknesses ofa given material prior to use in a patient), the balloon safety valve112 of the present invention for urethra applications is matched tobreak when the pressure inside or exerted on the balloon 110 approachesthe maximum urethra pressure.

In the embodiment shown in FIG. 2 , a decreased thickness is formed as afirst semi-circumferential groove 114 near a proximal end of the balloon110 and/or as a second semi-circumferential groove 116 near a distal endof the balloon 110. The grooves 114, 116 can have any cross-sectionalshape, including, trapezoidal, triangular, square, or rectangle, forexample. Because rubber, plastic, and silicone materials tear well withthinner cuts, a relatively triangular shape or one with a narrow bottomcan be an exemplary configuration. To make sure that the entire balloon110 of the illustrated embodiment does not completely tear away from thefluid drainage lumen 120, both grooves 114, 116 do not extend around theentire circumference of the balloon 110. As shown to the left of theproximal groove 116 in FIG. 2 , the groove 116 is not present on atleast an arc portion 118 of the circumference of the balloon 110. Thearc portion is defined to be sufficiently large so that, when thecatheter 100 is removed from the patient, the balloon 110 cannot tearaway entirely from the catheter 100 (and create the disadvantageousfragmentation situation as set forth above). The illustrated balloonsafety valve 112 is, therefore, fashioned to keep the balloon 110 in onepiece after breaking and remain firmly connected to the catheter 100 toinsure that no piece of the balloon 110 will be left inside the patientafter actuation of the balloon safety valve 112. Alternatively, thegroove can be along the length of the balloon parallel to the axis ofthe catheter. This groove can be made by skiving the balloon afterattaching to the catheter or by skiving the balloon as it is formedduring extrusion or dip molding. In this embodiment, when the pressureexceeds a predetermined limit, the balloon splits along the groovewithout releasing fragments.

It is noted that the balloon 110 is inflated through an inflation lumen130 having a proximal opening, typically formed by one end of a luerconnector (see 260 in FIG. 3 ). The illustrated end is connected to anon-illustrated inflation device, for example, a distal end of a syringefor inflation of the balloon 110.

In this first embodiment, the balloon can be of an elastomer, rubber,silicone, or plastic, for example. Once the balloon breaks, the catheteris useless and must be discarded. Because the balloon 110 in thisembodiment will break inside the patient, it should be inflated with abio-safe fluid to prevent unwanted air, gas, or bio-unsafe fluid fromentering the patient. In certain circumstances where balloon cathetersare used, air or gas will not injure the patient if let out into thepatient's body cavity. In such circumstances, the inflating fluid can beair under pressure, for example.

Maximum urethra pressure can also be tailored to the individual patient.Based upon a urethral pressure-measuring device, the patient's maximumurethra pressure can be measured before the catheter 100 is placedtherein. A set of catheters 100 having different safety valve breakingconstants can be available to the physician and, after estimating orcalculating or knowing the patient's maximum urethra pressure, thephysician can select the catheter 100 having a safety valve breakingconstant slightly or substantially smaller than the patient's maximumurethra pressure. Accordingly, if the pressure in the balloon 110approaches the patient's maximum urethra pressure for any reason,whether it is due to over-inflation, improper placement, and/orpremature removal, the balloon 110 is guaranteed to break prior to thepatient's lumen (in particular, the patient's urethra) and, therefore,prior to causing injury.

A second embodiment of the one-use breaking safety valve of apressure-limiting balloon catheter 200 is shown in FIG. 3 . The catheter200 has a fluid drainage lumen 220, a balloon inflation lumen 230, and asecondary lumen 240.

The fluid drainage lumen 220 is connected fluidically to the body cavity(i.e., the bladder 30) for draining fluid from the body cavity.

The secondary lumen 240 can be used for any purpose, for example, forhousing the radiation line that will supply energy to the radiation coil2. It can also be used for injecting fluid into any distal part of thecatheter 200 or even the body cavity itself.

The balloon inflation lumen 230 begins at a proximal end with aninflating connector 260 that, in an exemplary embodiment, is one part ofa luer connector. The balloon inflation lumen 230 continues through thebody of the catheter 200 all the way to the balloon 110 and isfluidically connected to the interior of the balloon 110.

Alternatively or additionally, the balloon safety valve is fluidicallyconnected to the balloon inflation lumen 230. In a second embodiment ofthe safety valve 212, the valve 212 is formed integrally with theballoon inflation lumen 230 and is set to open into the environment(instead of into the patient) if the maximum urethra pressure isexceeded in the balloon 110 or the balloon inflation lumen 230.Alternatively and not illustrated, the valve 212 is formed integrallywith the balloon inflation lumen 230 and is set to open into thedrainage lumen 220 if the maximum urethra pressure is exceeded in theballoon 110 or the balloon inflation lumen 230. A further alternativeincludes opening both into the environment and into the drainage lumen220. Because this safety valve 212 is located near or at the ballooninflation port 260 in this configuration, fluid used to inflate theballoon will not enter the patient when the valve 212 opens.

The safety valve 212 in the second embodiment can merely be a narrowingof the distance between the balloon inflation lumen 230 and the outersurface 250 of the catheter 220. In FIG. 3 , the valve 212 has arectangular cross-section and extends away from the balloon inflationlumen 230. As shown in FIGS. 4, 5, and 6 , respectively, thecross-section can be triangular (peaked or pyramidical inthree-dimensions), curved (circular or cylindrical in three-dimensions),or trapezoidal (frusto-conical or bar-shaped in three-dimensions). Thecross-sections are shown in FIGS. 3 to 7 with the narrowing emanatingfrom the balloon inflation lumen 230 outward. As an alternative, thenarrowing can begin on the outer surface of the catheter and extendinwards towards the balloon inflation lumen 230. A further alternativecan have the narrowing extend from both the inner lumen 230 and theouter surface of the catheter.

The cross-sections illustrated are merely exemplary. What is importantis that the thickness t between the bottom 213 of the valve 212 and theouter surface 250 of the catheter 220 in comparison to the thickness Tof the catheter body over the remainder of the balloon inflation lumen230. An enlarged view of this thickness comparison is illustrated inFIG. 7 . As long as the thickness t is smaller than the thickness T(t<T), and as long as the force F_(b) required to break the balloon isgreater than the force F_(sv) required to break the portion 213 of thesafety valve 212 (F_(b)>F_(sv)), then the portion 213 of the safetyvalve 212 is virtually guaranteed to break every time pressure exertinga force F in the balloon inflation lumen 230 is greater than the forceF_(sv) required to break the safety valve (F_(sv)>F).

Based upon this analysis, the force F_(sv) required to break the safetyvalve can be tuned to whatever a patient needs or a physician desiresand different sized valves can be available for any procedure andprovided in the form of a kit. Whether a standard maximum urethrapressure is used or a patient-specific maximum urethra pressure ismeasured and used, experiments can be conducted prior to use on apatient on various catheter thicknesses t to determine the pressureneeded to break the portion 213 of the safety valve 212. For example,ten different maximum urethra pressures can be known as desirable setpoints and the thicknesses t can be varied such that pressure requiredto break the ten thicknesses correspond to the ten set point pressures.If, then, ten catheters are placed in such a kit, each having one of theten thicknesses, then the physician has a range of 10 maximum urethrapressure values to use with the patient.

Although FIGS. 3 to 7 show indentations into the wall of the catheter,the indentation can be in the form of a through-hole entirely throughthe wall of the catheter communicating with the outside of the catheterover which is placed a sleeve. Depending upon the pressure in theinflation lumen, fluid can leak through the hole and lift up the sleeveand leak to atmosphere therefrom. Pressure is controlled in thisembodiment by the modulus of the sleeve material. A harder sleeve thatfits snugly on the catheter will not allow leakage at low pressure.Alternatively, a softer rubbery sleeve would lift up easily to releasehigh pressure fluid.

The safety valve 212 of the second embodiment need not be confined tothe body of the catheter 200. Instead, the inflating connector 260 can,itself, be equipped with the pressure relief valve 212. Alternatively, anon-illustrated modular attachment containing the safety valve 212 canbe attached to the inflating connector 260. Such a modular valveattachment is removable and replaceable (such as through a conventionalluer or even a screw-threaded connection). Accordingly, as long as thecatheter 200 can still be used after the valve 212 actuates (breaks),the used modular valve attachment can be replaced with a new attachment.The converse is also true for reuse of the attachment if the catheter200 breaks and the valve of the attachment remains unbroken. Adownstream end of the modular valve attachment (e.g., shaped as part ofa luer connector) is attached removably to an upstream end of theinflating connector 260 and the upstream end of the modular valveattachment is to be connected to the balloon inflation device, which iscommonly a syringe. The upstream end of the modular valve attachment is,likewise, part of a luer connector for easy connection to standardmedical devices. In such a configuration, the safety valve 212, 312 ofthe present invention can be entirely separate from the catheter 200,300 and, therefore, form a retrofitting device for attachment to anyluer connector part present on conventional catheters.

As an alternative to the one-use breaking safety valve of the secondembodiment, a multi-use pressure valve can be used. This thirdembodiment of the pressure-limiting balloon catheter 300 is illustratedin FIG. 8 . The catheter 300 can be the same as the catheter 200 in FIG.3 except for the portion illustrated in FIG. 8 . Instead of having anarrowing thickness t of the lumen wall, the valve portion 313 extendsentirely to the environment (and/or into the drainage lumen 220).However, a one-way valve 314 (shown only diagrammatically in FIG. 8 ) isattached to the open end of the valve portion 313 and is secured to theouter surface 250 of the catheter 300 to close off the open end of thevalve portion 313. The one-way valve 314 can be secured directly to theouter surface 250 (e.g., with an adhesive), or a connector 315 (e.g., athreaded cap) can secure the one-way valve 314 to the open end of thevalve portion 313. Regardless of the configuration, the one-way valve314 includes a device that does not permit fluid from exiting the lumen230 until a given resistance R is overcome. This given resistance R canbe selectable by the physician depending upon the one-way valve that ischosen for use if a set of one-way valves having different resistances Rare available for use by the physician. Just like the second embodiment,the resistance R can be set to correspond to desired maximum urethrapressure values. Therefore, when used, the fluid exits the one-way valve314 into the environment well before the patient's maximum urethrapressure is exceeded by the balloon.

The one-way valve 314 can be a mechanical one-way valve. Additionally,the one-way valve 314 can be a material having a tear strengthcorresponding to a desired set of resistances R. The material can be afluid-tight fabric, a rubber, a plastic, or silicone different from thematerial making up the catheter. The material can even be a rubber,plastic, or silicone the same as the material making up the catheter buthaving a reduced thickness t than the thickness T of the catheter.Alternatively, the one-way valve 314 can be a slit valve. Variousexemplary embodiments of such a valve can be found in U.S. Pat. No.4,995,863 to Nichols et al., which is hereby incorporated herein byreference in its entirety.

It can also be appreciated that the pressure release (or relief) valvecan be a conventional pressure release valve comprised of a housing witha lumen, a ball, and a spring within the lumen wherein the springpresses the ball against a defined opening. When pressure on the ballexceeds the force of the spring, the ball moves away from the definedopening and fluid moves around the ball and vents to atmosphere. Bycontrolling tension on the spring, the pressure at which the valvereleases pressure can be controlled. It can also be appreciated that thepressure release valve can be coupled to a Luer connector, which can becoupled to a one-way check valve that can be used to inflate the balloonas is often used in conventional urinary drainage catheters.

Because the safety valve 212, 312 is located at the proximal end of thecatheter 200, 300, the distal end of the catheter 200, 300 can take theform of a distal end of a conventional balloon catheter 2, 3, 4, 5.Alternatively, the distal end shown in FIG. 2 can also be used forredundant over-pressure protection.

In another exemplary embodiment of the present invention, FIGS. 9 to 18illustrate alternatives to the elastomeric balloon described above. Inparticular, the above elastomeric balloon is replaced by a thin walled,pre-formed, fixed diameter balloon 1010 that inflates with virtually nopressure and withstands pressures between approximately 0.2 atmospheres(2.9 psi) and 0.5 atmospheres (7.35 psi), the latter of which isapproximately equal to the maximum urethra pressure, without anappreciable increase in diameter. Examples of such balloon materials andthicknesses are used in the medical field already, such as those used inangioplasty. Other exemplary materials can be those used in commercial(party) balloons, for example, MYLAR®, or similar materials such asnylon, PTA, PTFE, polyethylene and polyurethane, for example. In FIGS. 9and 13 , the balloon 1010 is shown in a spherical shape. However, theballoon 1010 can be, for example, cylindrical with flat or conicallytapering ends.

The inflation balloon 1010 can be formed by heating a tubular materialwithin a mold or by heat-sealing thin sheets to one another (e.g., partyballoons have two sheets). One example of the relatively non-compliant,thin-walled balloon 1010 of the present invention is formed using ablow-molding process. In the blow-molding process, a thermoplasticmaterial such as nylon, polyurethane, or polycarbonate is extruded orformed into a hollow, tube-like shape (parison) and is subsequentlyheated and pressurized, usually with air, inside a hollow mold having ashape to form the final outer dimensions of the balloon. An example ofthe blow molded product is the common plastic soda or water bottlecontainers.

One exemplary, but not limiting, process to form the zero-pressureballoon of the present invention is described with respect to FIG. 11and includes, in Step 1110, cutting a relatively short piece of“parison” tubing that is formed using standard “air-mandrel” extrusiontechniques. In Step 1120, one end of the tubing is sealed. The centerportion of the tubing is placed in a hollow mold, leaving both endsextending outside of the mold in Step 1130. The center of the tubing isheated in Step 1140 with a hot stream of air through a small hole in thecenter of the mold for a few seconds to soften the tubing walls withinthe mold. The inside of the tubing is pressurized with a fluid, e.g.,air, in Step 1150 to stretch the tubing walls to conform to the insidedimensions of the mold. After a short cooling period, an additionalstretch of the formed balloon is done in Step 1160 by pulling on the(external) parison and, after a second “blowing” in the same mold inStep 1170, is used to create a very thin-walled balloon (much less than0.001 inches, typically, based upon the parison wall thickness and thefinal balloon diameter). The extra (unblown) parison tubing is then cutoff from both ends in Step 1180, leaving the thin walled, relativelysupple balloon and its “legs” to be mounted to the catheter as describedbelow.

This exemplary process can be used to create thin, non-compliantballoons for “angioplasty” of blood vessels at pressures exceeding 12atmospheres of pressure, for example. Although these pressures are notnecessary in the present application, it is witness to the fact thatvery strong thin-walled balloons can result from the above manufacturingprocess.

The present invention's thin, non-compliant zero-pressure balloon can beattached to the drainage catheter in a number of ways. In a firstexemplary attachment embodiment, reference is made to the process ofFIG. 12 , the slit valve of FIG. 13 , and the removable balloon of FIG.16 .

In an exemplary embodiment, each of the distal and proximal legs of theballoon 1010 manufactured according to the process of FIG. 12 isattached to the distal end of the drainage catheter using standard(e.g., FDA-approved) cements or by heat fusing the two pieces together.The non-compliant, thin-walled balloon is dimensioned to envelop the“slit valves” shown, for example, in FIG. 13 , as an exemplaryconfiguration of the invention. The balloon's thin walls allow foldingof the balloon without a significant increase in the catheter outerdiameter for ease in catheter insertion.

Exemplary embodiments of the internal balloon valve 1012 according tothe invention are illustrated in FIGS. 13, 14, and 15 . This internalballoon valve 1012 is formed by cutting the wall of the drainage lumen1120 at the portion of the catheter shaft 1020 within the balloon 1010.The slit can be a single cut or a plurality of cuts. Some exemplary slitvalves other than those shown are described in U.S. Pat. No. 4,995,863to Nichols et al., all of which can be utilized for the presentinvention. The slit-opening pressure, therefore, can be regulated byadjusting the number, length and spacing of the slit(s) and thethickness of the drainage lumen wall 1122. For example, the length andorientation of the slit(s) 1012 determines the pressure at which it/theywill open and drain the balloon inflation lumen 1130. In one particularembodiment shown in FIG. 15 , the slits 1124 are cut through theelastomeric walls in a way that results in a wedge-shaped cross-section.With this wedge shape, fluid within the balloon can drain under pressureeasily. The wedge can be increasing or decreasing. With the former, theedges are chamfered towards one another from the central axis of theballoon toward the exterior thereof (e.g., illustrated in FIG. 15 ) and,with the latter, the edges are chamfered towards one another from theexterior of the balloon toward the central axis.

In another exemplary embodiment, a non-illustrated, thin-walled slittedsleeve can be disposed over the portion of the drainage catheter wall1122 within the balloon 1010 and covering a throughbore fluidicallyconnecting the interior of the balloon 1010 to the interior of thedrainage lumen 1120. As such, pressure within the balloon 1010 will openthe slit(s) of the sleeve, thereby fluidically connecting the balloon1010 interior with the drainage lumen 1120 to transfer fluid in theballoon 1010 to the drainage lumen 1120. Each of these exemplary balloonconfigurations entirely prevents damage caused by improper inflation orpremature removal.

Alternatively, the balloon wall itself could be modified to burst at aparticular pressure to release the inflation media. This weakenedsection could be created by mechanical, chemical, or thermal treatmentfor example. Mechanical measures may be accomplished by scratching thesurface and, thus, thinning the balloon wall in a particular section tocause it to burst at a predetermined pressure or actually slicing orpunching a hole in the wall and covering the area with a thinner, weakerfilm of material which will tear at a predetermined pressure lower thanthe rest of the balloon. Likewise, a chemical solvent could be appliedto create the same effect as the mechanical device above by makingchemical changes to the plastic molecular structure of the balloon walland, thereby, weakening a desired section of the balloon wall. Weakeninga section of the wall by heat to thereby re-orient its molecularstructure (much like softening by annealing) is also possible.Therefore, the preferential tearing of the balloon wall at apredetermined internal pressure can be effected in a number of ways asexemplified by, but not limited to, the methods described above.

A second exemplary, but not limiting, process to attach thezero-pressure balloon of the present invention to the safety catheter1600 of the present invention, which can be used with or without theslit valves, is described with respect to FIGS. 12 and 16 and includes,in Step 1210, assembling a first proximal leg 1620 of the balloon 1610over the distal end of the drainage catheter shaft 1630 in an “inverted”direction (open end toward the balloon interior as shown in FIG. 16 ).This inverted connection is accomplished with a mechanical release thatcan be formed, for example, merely by using the shape of the proximalleg 1620 of the balloon 1610 or by using a separate compression device,such as an elastic band, or by using adhesives that removably connectthe proximal leg 1620 to the drainage catheter shaft 1630. In acompression only example, the proximal balloon seal is, thereby, formedby the force of the “inverted” relatively non-compliant proximal leg1620 being extended over and around the distal end of the flexibledrainage catheter shaft 1630 by, for example, stretching the material ofthe drainage catheter shaft 1630 (e.g., silicone) to reduce its outerdiameter. The other, distal leg 1640 of the balloon 1610 can, then, beattached in Step 1220 using cements (as in the first example above) orby heat fusion. It is noted that, while attachment is shown anddescribed in an inverted orientation for the proximal leg 1620 and in anon-inverted orientation for the distal leg 1640, these are not the onlypossible orientations for each and can be assembled in any combinationof inverted and non-inverted orientations. For example, the distal leg1640 can, as the proximal leg 1620, be attached in an inverted directionnot illustrated in FIG. 16 .

To further aid in balloon assembly and catheter deflation and insertion,the outer diameter of the catheter 1600 under the balloon 1610, as wellas the inner diameter of the distal balloon leg 1640, can be reduced ascompared with the outer diameter of the drainage catheter shaft 1630,which configuration is shown in FIGS. 16 to 19 . The reduced-diameterportion of the catheter 1600 is referred herein as the distal tipportion 1650 and extends from the distal end of the drainage cathetershaft 1630 at least to the distal end of the distal balloon leg 1640. Asshown, the distal tip 5 (distal of the balloon 1610) also can have thesame reduced diameter (or can be reduced further or increased larger asdesired). Thus, if the outer diameter of the distal tip portion 1650 isreduced immediately distal of the proximal balloon seal 1620, anypredetermined pull force will stretch the catheter shaft 1630, therebyreducing the outer diameter of the catheter shaft 1630 at the proximalballoon seal and allowing the proximal balloon leg 1620 to slide or peeldistally and deflate the balloon quickly, at which time all fluid isreleased therefrom into the bladder or urethra, for example. It isenvisioned that the proximal balloon leg 1620 can be mounted with theballoon leg 1620 in a non-inverted or “straight” position if desiredwith similar results. However, in such a configuration, sliding of theproximal leg 1620 over the distal end of the catheter shaft 1630 may bemore resistant to a pulling force on the exposed proximal end of thecatheter shaft 1630 but the slight incursion of the balloon-fillingfluid can be used to lubricate this connection and, therefore, theresistance to pulling decreases.

With a zero-pressure configuration as described and referred to herein,the balloon 1010, 1610 is under zero-pressure or low pressure. Thus, theinflation device (e.g., a syringe) need not be configured to deliverpressure much above the low pressure range described above. Merepresence of the filling liquid in the balloon, makes the balloon largeenough to resist and prevent movement of the balloon into the urethraand out of the bladder without having an internal, high pressure. Assuch, when inserted improperly in the urethra, the balloon will simplynot inflate because there is no physical space for the balloon to expandand because the inflation pressure remains beneath the urethral damagingpressure threshold. If the inflation device is configured for lowpressure, even maximum delivered pressure to the balloon will beinsufficient to inflate the balloon within the urethra, therebypreventing any possibility of balloon inflation inside the urethra.

In the other case where the balloon is inflated properly within thebladder but the catheter is improperly removed out from the patientwithout deflating the balloon, safety devices of the invention preventtearing of the urethra upon exit. Any combination of the internalballoon valve 1012 (e.g., the slit valve of FIG. 13 formed through thewall of a portion of the drainage lumen 1120 located inside the balloon1010, 1610) and the removable proximal balloon seal 1620 can be used;one or both can be employed to provide the safety features of theinvention. In operation, when a predetermined inflation pressure isreached, the internal balloon valve 1012 opens and any fluid in theballoon 1010, 1610 is emptied through the drainage lumen 1120 into thebladder (distal) and/or the external drain bag (proximal), the latter ofwhich is not illustrated. As set forth above, the point at whichpressure causes the internal balloon valve 1012 to open is defined to beless than the pressure needed to damage the urethra when a fullyinflated prior-art balloon catheter is improperly removed as describedherein. In a low-pressure state, in which the balloon 1010, 1610 isfilled with a fluid (either liquid or gas), there is not enough pressureto force open the internal balloon valve 1012 and permit exit of thefluid out from the balloon 1010, 1610. In a higher-pressure state (belowurethra damage pressure), in contrast, pressure exerted on the fluid issufficient to open the internal balloon valve 1012, thus permitting thefluid to quickly drain out of the balloon 1010, 1610 and into thedrainage lumen 1120.

In a situation where the balloon 1010, 1610 is in the urethra andinflation is attempted, pressure exerted by the surrounding urethralwall on the inflating balloon 1010, 1610 will cause the internal balloonvalve 1012 to open up well before the balloon 1010, 1610 could inflate.Thus, the balloon inflation fluid will, instead of filling the balloon1010, 1610, exit directly into the drainage lumen 1120. In analternative embodiment, the fluid used for inflation can be colored tocontrast with urine (or any other fluid that is envisioned to passthrough the drainage lumen). Thus, if the balloon 1010, 1610 is insertedonly into the urethra and inflation is attempted, the inflating fluidwill immediately exit into the drainage lumen and enter the exterior(non-illustrated) drain bag. Thus, within a few seconds, the technicianwill know if the balloon 1010, 1610 did not enter the bladder andinflate therein properly by seeing the colored inflation fluid in thedrain bag. In such a situation, the technician needs to only insert thecatheter further into the urethra and attempt inflation again. Theabsence of further colored inflation fluid in the drain bag indicatesthat correct balloon inflation occurred.

To enhance placement of this catheter in the bladder in the idealposition, in an alternative exemplary embodiment, a visual aid 1030,1032 for insertion is provided by marking the catheter shaft 1020. Thisvisual aid can be on the exterior surface or it can be embedded withinthe material comprising the shaft as long as it is visible to medicalpersonnel. For, example, it could be an embedded band of colored plasticor radiopaque material, or it could just be an inked circumferentialline. Because male and female patients have urethras of differentlengths, a first marker 1030 can be used to indicate an average urethralength 1031 for a male and a second marker 1032 can be used to indicatean average urethra length 1033 for a female.

In this way, if, after believing that insertion is “correct,” the userstill sees the marking outside the patient, the user can double checkthe insertion before inflating the balloon (which would occur in theurethra if not installed far enough therein) and entirely preventinjury-causing inflation within the urethra. Additionally, thesemarkings 1030, 1032 can provide immediate indications to medicalpersonnel when it is not known that a patient has jerked out thecatheter partially or the catheter snagged on the environment and pulledout partially. In either situation, if the medical personnel looks atthe catheter and sees the respective marking 1030, 1032, then it becomesimmediately clear that the inflated balloon catheter has been improperlyremoved, but partially, and immediate corrective action can be taken.

It is noted that this marking feature is only being shown on thecatheter of FIG. 9 for illustrative purposes. It is not intended to belimited to the catheter of FIG. 9 and is to be understood as applying toany and/or all of the exemplary embodiments described herein.

In the situation where the balloon 1010, 1610 is inflated within thebladder and the catheter 100 is pulled out from the bladder withoutdeflating the balloon 1010, 1610, pressure exerted by the wall 2022 atthe bladder-urethral junction 11 upon the inflated balloon 1010, 1610will cause the valve 1012 to open up quickly and cause fluid flow intothe drainage lumen 1120 before injury occurs to the junction 11 or theurethra. If, in such a situation, the catheter is also equipped with theremovable balloon end (e.g., proximal end 1620), then, as the removableballoon end is peeling off, the slit valve opens up to relieve pressureeither before or at the same time the peeling off occurs. This allowsthe inflation fluid to exit even faster than if just the valve 1012 ispresent.

FIGS. 16 to 18 illustrate an exemplary embodiment of the inventivecatheter 1600 with the everting removable balloon 1610. These figuresillustrate the situation where the balloon 1610 is inflated within thebladder and, as indicated by the pull arrow, the catheter 1600 is pulledout from the bladder without deflating the balloon 1610. Here, thedistal seal 1640 of the balloon 1610 is fixed to the distal tip portion1650 of the catheter 1600, which tip 5 has a reduced outer diameter ascompared to the drainage catheter shaft 1630, and the proximal seal 1620is removably attached (e.g., with a compression seal) to the drainagecatheter shaft 1630. The pulling force causes the drainage cathetershaft 1630 to move in the proximal direction out of the urethra and,thereby, compress the proximal side of the inflated balloon 1610 againstthe bladder-urethral junction 11. As the catheter shaft 1630 movesproximally, the force on the proximal seal 1620 increases until the seal1620 breaks free of the catheter shaft 1630, referred to herein as thebreakaway point. FIG. 17 illustrates the now partially inflated balloon1610 just after the breakaway point. Because the diameter of the distaltip portion 1650 is reduced in comparison to the distal end of thecatheter shaft 1630, a gap opens up between the inner diameter of theproximal seal portion of the balloon 1610 and the outer diameter of thedistal tip portion 1650. This gap allows the inflating fluid to exit theballoon 1610 quickly into one or both of the urethra and the bladderbefore injury occurs to the junction 11 or to the urethra. As thecentral portion of the balloon 1610 is still larger than the urethralopening of the junction 11, the friction and force imparted on theballoon 1610 causes the balloon 1610 to roll over itself, i.e., evert,until it is entirely everted as shown in FIG. 18 . At this time, all ofthe inflating fluid is either in the urethra and/or in the bladder.

In an exemplary embodiment of the removable proximal balloon seal 1620,a pulling force in a range of 1 to 15 pounds will cause the proximalballoon seal 1620 to pull free and allow eversion of the balloon 1610,i.e., the breakaway point. In another exemplary embodiment, the range offorce required to meet the breakaway point is between 1 and 5 pounds, inparticular, between 1.5 and 2 pounds.

With regard to additional exemplary embodiments of self-deflating orautomatically deflating balloon catheters according to the invention,FIGS. 19 and 20 are provided to illustrate the construction andprocesses for manufacturing prior art urinary catheters, also referredto as Foley catheters. Although prior art urinary catheters are usedherein to assist in the understanding of the exemplary embodiments ofurinary balloon catheters according to the invention, neither are usedherein to imply that the invention is solely applicable to urinary-typecatheters. Instead, the technology described herein can be applied toany balloon catheter, including all mentioned herein.

FIG. 19 shows the balloon portion of the prior art catheter 1900 withthe balloon in its uninflated state. An annular inner lumen wall 1910(red) defines therein a drainage lumen 1912. At one circumferentiallongitudinal extent about the inner lumen wall 1910, an inflation lumenwall 1920 (orange) defines an inflation lumen 1922 and a ballooninflation port 1924 fluidically connected to the inflation lumen 1922;in standard urinary catheters, there is only one inflation lumen 1922and one inflation port 1924. The views of FIGS. 19 and 20 show across-section through the inflation lumen 1922 and inflation port 1924.If the inflation lumen 1922 extended all of the way through the catheter1900 to its distal end (to the left of FIGS. 19 and 20 ), then theballoon could not inflate as all inflation liquid would exit the distalend. Therefore, in order to allow inflation of the balloon, a lumen plug1926 (black) closes the inflation lumen 1922 distal of the inflationport 1924. In this exemplary illustration, the lumen plug 1926 starts ata position distal of the inflation port 1924 at the inflation lumen1922.

About the inner lumen and inflation lumen walls 1910, 1920 around theinflation port 1924 is a tube of material that forms the ballooninterior wall 1930 (green). The tube forming the balloon interior wall1930 is fluid-tightly sealed against the respective inner walls 1910,1920 only at the proximal and distal ends of the tube. Accordingly, apocket is formed therebetween. An outer wall 1940 (yellow) covers all ofthe walls 1910, 1920, 1926, 1930 and does so in what has referred toherein as a fluid-tight manner, meaning that any fluid used to blow upthe balloon through the inflation lumen 1922 and the inflation port 1924will not exit the catheter 1900 through the fluid-tight connection. FIG.20 illustrates the fluid inflating the balloon (indicated with dashedarrows). Because at least the balloon interior wall 1930 and the outerwall 1940 are elastomeric, pressure exerted by the inflating fluid 2000against these walls will cause them to balloon outwards as, for example,shown in FIG. 20 . When the non-illustrated proximal end of the catheter1900 is sealed with the fluid 2000 therein (e.g., with at least a partof a luer connector as shown in FIG. 3 ), the catheter 1900 will remainin the shape shown in FIG. 20 .

As set forth above, the balloon 2010 of a urinary catheter should beinflated only when in the bladder 2020. FIG. 20 shows the catheter 1900correctly inflated in the bladder 2020 and then, if needed, pulledproximally so that the inflated balloon 2010 rests against andsubstantially seals off the urethra 2030 from the interior of thebladder 2020. “Substantially,” as used in this regard means that most orall of the urine in the bladder 2020 will drain through the drain lumen1912 and will not pass around the inflated balloon 2010 more than istypical and/or required for correctly implanted urinary catheters. It isknown that an insubstantial amount of urine will pass the balloon 2010and, advantageously, lubricate the urethra 2030 but will not leak outthe end of the urethra as muscles in the various anatomy of males andfemales will seal the end with sufficient force to prevent significantleakage.

Even though each of the walls is shown in different colors herein, thedifferent colors do not imply that the respective walls must be made ofdifferent materials. These colors are used merely for clarity purposesto show the individual parts of the prior art and inventive cathetersdescribed herein. As will be described in further detail below, most ofthe different colored walls actually are, in standard urinary catheters,made of the same material. Some of the biocompatible materials used forstandard Foley catheters include latex (natural or synthetic), siliconerubber, and thermoplastic elastomers (TPEs) including styrenic blockcopolymers, polyolefin blends, elastomeric alloys (TPE-v or TPV),thermoplastic polyurethanes, thermoplastic copolyester, andthermoplastic polyamides.

One exemplary process for creating the prior art urinary cathetersstarts with a dual lumen extrusion of latex. The dual lumen, therefore,already includes both the drainage lumen 1912 and the inflation lumen1922. Both lumen 1912, 1922, however, are extruded without obstructionand without radial ports. Therefore, in order to have the inflation port1924, a radial hole is created from the outside surface inwards to theinflation lumen. Sealing off of the distal end of the inflation lumen1922 is performed in a subsequent step. The tube making up the innerballoon wall 1930 is slid over the distal end of the multi-lumenextrusion 1910, 1920 to cover the inflation port and is fluid-tightlysealed to the inner multi-lumen extrusion at both ends of the tube butnot in the intermediate portion. This tube can be made of latex as welland, therefore, can be secured to the latex multi-lumen extrusion in anyknown way to bond latex in a fluid-tight manner. At this point, theentire sub-assembly is dipped into latex in its liquid form to createthe outer wall 1940. The latex is allowed to enter at least a portion ofthe distal end of the inflation lumen 1922 but not so far as to blockthe inflation port 1924. When the latex cures, the balloon 2010 is fluidtight and can only be fluidically connected to the environment throughthe non-illustrated, proximal-most opening of the inflation port, whichis fluidically connected to the inflation lumen 1922. In this process,the inner wall 1910, the inflation lumen wall 1920, the plug 1926, theballoon inner wall 1930, and the outer wall 1940 are all made of thesame latex material and, therefore, together form a very securewater-tight balloon 2010.

As set forth above, all prior art balloon catheters are designed todeflate only when actively deflated, either by a syringe similar to theone that inflated it or by surgery after the physician diagnoses theballoon as not being able to deflate, in which circumstance, a procedureto pop the balloon surgically is required.

Described above are various embodiments of self-deflating orautomatically deflating catheters according to the invention. FIGS. 21to 33 illustrate automatically deflating, stretch-valve ballooncatheters in still other exemplary embodiments of the present invention.FIGS. 21 to 23 show a first exemplary embodiment of a stretch-valveballoon catheter 2100 according to the invention, FIG. 21 illustratingthe balloon portion of the inventive catheter 2100 with the balloon inits uninflated state. An annular inner lumen wall 2110 (red) definestherein a drainage lumen 2112. At one or more circumferentiallongitudinal extents about the inner lumen wall 2110, an inflation lumenwall 2120 (orange) defines an inflation lumen 2122 and a ballooninflation port 2124 fluidically connected to the inflation lumen 2122;in the inventive catheter, there can be more than one inflation lumen2122 and corresponding inflation port 2124 even though only one is shownherein. Accordingly, the views of FIGS. 21 to 23 show a cross-sectionthrough the single inflation lumen 2122 and single inflation port 2124.A lumen plug 2126 (black) closes the inflation lumen 2122 distal of theinflation port 2124. In this exemplary illustration, the lumen plug 2126starts at a position distal of the inflation port 2124 at the inflationlumen 2122. This configuration is only exemplary and can start at theinflation port 2124 or anywhere distal thereof.

About the inner lumen and inflation lumen walls 2110, 2120 around theinflation port 2124 is a tube of material that forms the ballooninterior wall 2130 (green). The tube of the balloon interior wall 2130is fluid-tightly sealed against the respective inner walls 2110, 2120only at the proximal and distal ends of the tube. Accordingly, a pocketis formed therebetween. An outer wall 2140 (yellow) covers all of thewalls 2110, 2120, 2126, 2130 in a fluid-tight manner. FIG. 21illustrates the fluid about to inflate the balloon (indicated withdashed arrows). Because at least the balloon interior wall 2130 and theouter wall 2140 are elastomeric, pressure exerted by the inflating fluid2200 against these walls will cause them to balloon outwards as, forexample, shown in FIG. 22 . When the non-illustrated proximal end of thecatheter 2100 is sealed with the fluid 2200 therein (e.g., with at leasta part of a luer connector as shown in FIG. 3 ), the catheter 2100 willremain in the shape shown in FIG. 22 .

FIG. 22 shows the catheter 2100 correctly inflated in the bladder 2020and then, if needed, pulled proximally so that the inflated balloon 2210rests against and substantially seals off the urethra 2030 from theinterior of the bladder 2020.

The stretch-valve of the exemplary embodiment of FIGS. 21 to 23 hasthree different aspects. The first is a hollow, stretch-valve tube 2220that is disposed in the inflation lumen 2122 to not hinder inflation ofthe balloon 2210 with the fluid 2200. While the diameter of thestretch-valve tube 2220 can be any size that accommodates substantiallyunhindered fluid flow through the inflation lumen 2122, one exemplaryinner diameter of the stretch-valve tube 2220 is substantially equal tothe diameter of the inflation lumen 2122 and the outer diameter of thestretch-valve tube 2220 is just slightly larger than the diameter of theinflation lumen 2122 (e.g., the wall thickness of the tube can bebetween 0.05 mm and 0.2 mm). The proximal end of the stretch-valve tube2220 in this exemplary embodiment is proximal of a proximal end of theballoon inner wall 2130. The distal end of the stretch-valve tube 2220is somewhere near the proximal end of the balloon inner wall 2130; thedistal end can be proximal, at, or distal to the proximal end of theballoon inner wall 2130 and selection of this position is dependent uponthe amount of stretch S required to actuate the stretch-valve of theinventive catheter 2100 as described below. Another exemplary embodimentof the stretch-valve tube 2220 has one or more of the proximal anddistal ends thereof larger in outer diameter than an intermediateportion of the stretch-valve tube 2220. Thus, if one end is larger, thestretch-valve tube 2220 has a “club” shape and, if both ends are larger,the stretch-valve tube 2220 has a “dumbbell” shape. An exemplaryconfiguration of a dumbbell shaped stretch-valve tube is describedhereinbelow.

In FIG. 22 , the distal end of the stretch-valve tube 2220 is shown atthe proximal end of the balloon inner wall 2130. Two ports are formedproximal of the balloon 2210. A proximal port (purple) 2150 is formedthrough the outer wall 2140 and through the inflation lumen wall 2020overlapping at least a portion of the proximal end of the stretch-valvetube 2220. In this manner, a portion of the outer surface of theproximal end of the stretch-valve tube 2220 at the proximal port 2150 isexposed to the environment but there is no fluid communication with theinflation lumen 2122 and the proximal port 2150. A distal port (white)2160 is formed through the outer wall 2140 and through the inflationlumen wall 2020 overlapping at least a portion of the distal end of thestretch-valve tube 2220. In this manner, a portion of the outer surfaceof the distal end of the stretch-valve tube 2220 at the distal port 2160is exposed to the environment but there is no fluid communication fromthe inflation lumen 2122 to the distal port 2160. To secure thestretch-valve tube 2220 in the catheter 2100, the proximal port 2150 isfilled with a material that fixes the proximal end of the stretch-valvetube 2220 to at least one of the outer wall 2140 and the inflation lumenwall 2020. In one exemplary embodiment, an adhesive bonds the proximalend of the stretch-valve tube 2220 to both the outer wall 2140 and theinflation lumen wall 2120.

In such a configuration, therefore, any proximal movement of thecatheter 2100 at or proximal of the proximal port 2150 will also movethe stretch-valve tube 2220 proximally; in other words, the distal endof the stretch-valve tube 2220 can slide S within the inflation lumen2122 in a proximal direction. FIG. 23 illustrates how the slide-valve ofthe invention operates when the proximal end of the catheter 2100 ispulled with a force that is no greater than just before injury wouldoccur to the bladder-urethral junction or the urethra if the catheter2100 was still inflated when the force was imparted. In an exemplaryembodiment of the stretch valve of FIGS. 21 to 23 , a pulling force in arange of 1 to 15 pounds will cause the stretch-valve tube 2220 to slideproximally S to place the distal end of the stretch-valve tube 2220 justproximal of the distal port 2160, i.e., the deflation point of thestretch-valve shown in FIG. 23 . In another exemplary embodiment, therange of force required to meet the deflation point is between 1 and 5pounds, in particular, between 1.5 and 2 pounds.

As can be seen in FIG. 23 , when the deflation point of thestretch-valve is reached, the interior of the balloon 2210 becomesfluidically connected to the distal port 2160. Because the distal port2160 is open to the environment (e.g., the interior of the bladder 2020)and due to the fact that the bladder is relatively unpressurized ascompared to the balloon 2210, all internal pressure is released from theballoon 2210 to eject the inflating fluid 2200 into the bladder 2020(depicted by dashed arrows), thereby causing the balloon 2210 to deflaterapidly (depicted by solid opposing arrows). It is noted that thedistance X (see FIG. 22 ) between the inflation port 2124 and the distalport 2160 directly impacts the rate at which the balloon 2120 deflates.As such, reducing this distance X will increase the speed at which theballoon 2210 deflates. Also, the cross-sectional areas of the inflationport 2124, the inflation lumen 2122, and the distal port 2160 directlyimpact the rate at which the balloon 2220 deflates. Further, any changesin direction of the fluid can hinder the rate at which the balloondeflates. One way to speed up deflation can be to shape the distal port2160 in the form of a non-illustrated funnel outwardly expanding fromthe inflation lumen 2122. Another way to speed up deflation is to havetwo or more inflation lumens 2122 about the circumference of the innerlumen wall 2110 and to have corresponding sets of a stretch-valve tube2220, a proximal port 2150, and a distal port 2160 for each inflationlumen 2122.

Still another possibility for rapidly deflating an inflated balloon isto drain the fluid 2200 into the drain lumen 2112 instead of thebladder. This exemplary embodiment is illustrated in FIGS. 24 to 26 .FIG. 24 illustrates the balloon portion of the inventive catheter 2400with the balloon in its uninflated state. An annular inner lumen wall2410 (red) defines therein a drainage lumen 2412. At one or morecircumferential longitudinal extents about the inner lumen wall 2410, aninflation lumen wall 2420 (orange) defines an inflation lumen 2422 and aballoon inflation port 2424 fluidically connected to the inflation lumen2422; in the inventive catheter, there can be more than one inflationlumen 2422 and corresponding inflation port 2424 even though only one isshown herein. Accordingly, the views of FIGS. 24 to 26 show across-section through the single inflation lumen 2422 and singleinflation port 2424. A lumen plug 2426 (black) closes the inflationlumen 2422 distal of the inflation port 2424. In this exemplaryillustration, the lumen plug 2426 starts at a position distal of theinflation port 2424 at the inflation lumen 2422. This configuration isonly exemplary and can start at the inflation port 2424 or anywheredistal thereof.

About the inner lumen and inflation lumen walls 2410, 2420 around theinflation port 2424 is a tube of material that forms the ballooninterior wall 2430 (green). The tube of the balloon interior wall 2430is fluid-tightly sealed against the respective inner walls 2410, 2420only at the proximal and distal ends of the tube. Accordingly, a pocketis formed therebetween. An outer wall 2440 (yellow) covers all of thewalls 2410, 2420, 2426, 2430 in a fluid-tight manner. FIG. 24illustrates the fluid about to inflate the balloon (indicated withdashed arrows). Because at least the balloon interior wall 2430 and theouter wall 2440 are elastomeric, pressure exerted by the inflating fluid2200 against these walls will cause them to balloon outwards as, forexample, shown in FIG. 25 . When the non-illustrated proximal end of thecatheter 2400 is sealed with the fluid 2200 therein (e.g., with at leasta part of a luer connector as shown in FIG. 3 ), the catheter 2400 willremain in the shape shown in FIG. 25 .

FIG. 25 shows the catheter 2400 correctly inflated in the bladder 2020and then, if needed, pulled proximally so that the inflated balloon 2510rests against and substantially seals off the urethra 2030 from theinterior of the bladder 2020.

The stretch-valve of the exemplary embodiment of FIGS. 24 to 26 hasthree different aspects. The first is a hollow, stretch-valve tube 2520that is disposed in the inflation lumen 2422 to not hinder inflation ofthe balloon 2510 with the fluid 2200. While the diameter of thestretch-valve tube 2520 can be any size that accommodates substantiallyunhindered fluid flow through the inflation lumen 2422, one exemplaryinner diameter of the stretch-valve tube 2520 is substantially equal tothe diameter of the inflation lumen 2422 and the outer diameter of thestretch-valve tube 2520 is just slightly larger than the diameter of theinflation lumen 2122 (e.g., the wall thickness of the tube can bebetween 0.05 mm and 0.2 mm). The proximal end of the stretch-valve tube2520 in this exemplary embodiment is disposed proximal of a proximal endof the balloon inner wall 2430. The distal end of the stretch-valve tube2520 is somewhere near the proximal end of the balloon inner wall 2430;the distal end can be proximal, at, or distal to the proximal end of theballoon inner wall 2430 and selection of this position is dependent uponthe amount of stretch S required to actuate the stretch-valve of theinventive catheter 2400 as described below. Another exemplary embodimentof the stretch-valve tube 2520 has one or more of the proximal anddistal ends thereof larger in outer diameter than an intermediateportion of the stretch-valve tube 2520. Thus, if one end is larger, thestretch-valve tube 2520 has a “club” shape and, if both ends are larger,the stretch-valve tube 2520 has a “dumbbell” shape. An exemplaryconfiguration of a dumbbell shaped stretch-valve tube is describedhereinbelow.

In the exemplary embodiment of FIG. 25 , the distal end of thestretch-valve tube 2520 is shown at proximal end of the balloon innerwall 2430. Two ports are formed, one proximal of the balloon 2510 andone proximal of the inflation port 2424. A proximal port (purple) 2450is formed through the outer wall 2440 and through the inflation lumenwall 2420 to overlap at least a portion of the proximal end of thestretch-valve tube 2520. In this manner, a portion of the outer surfaceof the proximal end of the stretch-valve tube 2520 at the proximal port2450 is exposed to the environment but there is no fluid communicationbetween the inflation lumen 2422 and the proximal port 2450. A distalport (white) 2460 is formed through the inner lumen wall 2410 anywhereproximal of the inflation port 2424 to overlap a least a portion of thedistal end of the stretch-valve tube 2520. In this manner, a portion ofthe outer surface of the distal end of the stretch-valve tube 2520 atthe distal port 2460 is exposed to the drainage lumen 2412 but there isno fluid communication between the inflation lumen 2422 and the distalport 2460. To secure the stretch-valve tube 2520 in the catheter 2400,the proximal port 2450 is filled with a material that fixes the proximalend of the stretch-valve tube 2520 to at least one of the outer wall2440 and the inflation lumen wall 2420. In one exemplary embodiment, anadhesive bonds the proximal end of the stretch-valve tube 2520 to boththe outer wall 2440 and the inflation lumen wall 2420.

In such a configuration, therefore, any proximal movement of thecatheter 2400 at or proximal to the proximal port 2450 will also movethe stretch-valve tube 2520 proximally; in other words, the distal endof the stretch-valve tube 2520 can slide S within the inflation lumen2422 in a proximal direction. FIG. 26 illustrates how the slide-valve ofthe invention operates when the proximal end of the catheter 2400 ispulled to a force that is no greater than just before injury would occurto the bladder-urethral junction or the urethra if the catheter 2400 wasstill inflated when the force was imparted. In an exemplary embodimentof the stretch valve of FIGS. 24 to 26 , a pulling force in a range of 1to 15 pounds will cause the stretch-valve tube 2520 to slide proximallyS to place the distal end of the stretch-valve tube 2520 just proximalof the distal port 2460, i.e., the deflation point of the stretch-valveshown in FIG. 26 . In another exemplary embodiment, the range of forcerequired to meet the deflation point is between 1 and 5 pounds, inparticular, between 1.5 and 2 pounds.

As can be seen in FIG. 26 , when the deflation point of thestretch-valve is reached, the interior of the balloon 2510 becomesfluidically connected to the distal port 2460. Because the distal port2460 is open to the drainage lumen 2412 (which is open the interior ofthe bladder 2020 and the non-illustrated, proximal drainage bag) and dueto the fact that the bladder is relatively unpressurized as compared tothe balloon 2510, all internal pressure is released from the balloon2510 to eject the inflating fluid 2200 into the drainage lumen 2412(depicted by dashed arrows in FIG. 26 ), thereby causing the balloon2510 to deflate rapidly (depicted by solid opposing arrows in FIG. 26 ).Again, it is noted that the distance X between the inflation port 2424and the distal port 2460 (see FIG. 25 ) directly impacts the rate atwhich the balloon 2510 deflates. As such, having this distance X besmaller will increase the speed at which the balloon 2510 deflates.Also, the cross-sectional areas of the inflation port 2424, theinflation lumen 2422, and the distal port 2460 directly impact the rateat which the balloon 2120 deflates. Further, any changes in direction ofthe fluid can hinder the rate at which the balloon deflates. One way tospeed up deflation can be to shape the distal port 2460 in the form of afunnel outwardly expanding from the inflation lumen 2422. Another way tospeed up deflation can be to have two or more inflation lumens 2422about the circumference of the inner lumen wall 2410 and to havecorresponding sets of a stretch-valve tube 2520, a proximal port 2450,and a distal port 2460 for each inflation lumen 2422.

Yet another exemplary embodiment that is not illustrated herein is tocombine both of the embodiments of FIGS. 21 to 23 and 24 to 26 to havethe fluid 2200 drain out from both of the distal ports 2160, 2460 intoboth the bladder 2020 and the drain lumen 2112, respectively.

Still another possibility for rapidly deflating an inflated balloon isto drain the fluid 2200 directly into the drain lumen 2712 in a straightline without any longitudinal travel X. This exemplary embodiment isillustrated in FIGS. 27 to 29 . FIG. 27 illustrates the balloon portionof the inventive catheter 2700 with the balloon in its uninflated state.An annular inner lumen wall 2710 (red) defines therein a drainage lumen2712. At one or more circumferential longitudinal extents about theinner lumen wall 2710, an inflation lumen wall 2720 (orange) defines aninflation lumen 2722 and a balloon inflation port 2724 fluidicallyconnected to the inflation lumen 2722; in the inventive catheter, therecan be more than one inflation lumen 2722 and corresponding inflationport 2724 even though only one is shown herein. Accordingly, the viewsof FIGS. 27 to 29 show a cross-section through the single inflationlumen 2722 and single inflation port 2724. A lumen plug 2726 (black)closes the inflation lumen 2722 distal of the inflation port 2724. Inthis exemplary illustration, the lumen plug 2726 starts at a positiondistal of the inflation port 2724 at the inflation lumen 2722. Thisconfiguration is only exemplary and can start at the inflation port 2724or anywhere distal thereof.

About the inner lumen and inflation lumen walls 2710, 2720 around theinflation port 2724 is a tube of material that forms the ballooninterior wall 2730 (green). The tube of the balloon interior wall 2730is fluid-tightly sealed against the respective inner walls 2710, 2720only at the proximal and distal ends of the tube. Accordingly, a pocketis formed therebetween. An outer wall 2740 (yellow) covers all of thewalls 2710, 2720, 2726, 2730 in a fluid-tight manner. FIG. 27illustrates the fluid about to inflate the balloon (indicated withdashed arrows). Because at least the balloon interior wall 2730 and theouter wall 2740 are elastomeric, pressure exerted by the inflating fluid2200 against these walls will cause them to balloon outwards as, forexample, shown in FIG. 28 . When the non-illustrated proximal end of thecatheter 2700 is sealed with the fluid 2200 therein (e.g., with at leasta part of a luer connector as shown in FIG. 3 ), the catheter 2700 willremain in the shape shown in FIG. 28 .

FIG. 28 shows the catheter 2700 correctly inflated in the bladder 2020and then, if needed, pulled proximally so that the inflated balloon 2810rests against and substantially seals off the urethra 2030 from theinterior of the bladder 2020.

The stretch-valve of the exemplary embodiment of FIGS. 27 to 29 hasthree different aspects. The first is a hollow, stretch-valve tube 2820that is disposed in the inflation lumen 2722 to not hinder inflation ofthe balloon 2810 with the fluid 2200. While the diameter of thestretch-valve tube 2820 can be any size that accommodates substantiallyunhindered fluid flow through the inflation lumen 2722, one exemplaryinner diameter of the stretch-valve tube 2820 is substantially equal tothe diameter of the inflation lumen 2722 and the outer diameter of thestretch-valve tube 2820 is just slightly larger than the diameter of theinflation lumen 2722 (e.g., the wall thickness of the tube can bebetween 0.05 mm and 0.2 mm). The proximal end of the stretch-valve tube2820 in this exemplary embodiment is proximal of a proximal end of theballoon inner wall 2730. The distal end of the stretch-valve tube 2820is somewhere near the proximal end of the balloon inner wall 2730; thedistal end can be proximal, at, or distal to the proximal end of theballoon inner wall 2730 and selection of this position is dependent uponthe amount of stretch S required to actuate the stretch-valve of theinventive catheter 2700 as described below. Another exemplary embodimentof the stretch-valve tube 2820 has one or more of the proximal anddistal ends thereof larger in outer diameter than an intermediateportion of the stretch-valve tube 2820. Thus, if one end is larger, thestretch-valve tube 2820 has a “club” shape and, if both ends are larger,the stretch-valve tube 2820 has a “dumbbell” shape. An exemplaryconfiguration of a dumbbell shaped stretch-valve tube is describedhereinbelow.

In the exemplary embodiment of FIG. 28 , the distal end of thestretch-valve tube 2820 is shown between the inflation port 2724 and theproximal end of the balloon inner wall 2730. Two ports are formed, oneproximal of the balloon 2810 and one between the inflation port 2724 andthe proximal end of the balloon inner wall 2730. A proximal port 2750 isformed through the outer wall 2740 through the inflation lumen wall 2720to overlap at least a portion of the proximal end of the stretch-valvetube 2820. In this manner, a portion of the outer surface of theproximal end of the stretch-valve tube 2820 at the proximal port 2750 isexposed to the environment but there is no fluid communication betweenthe inflation lumen 2722 and the proximal port 2750. A distal port(white) 2760 is formed through both inflation lumen wall 2720 and theinner wall 2710 distal of the proximal connection of the balloon innerwall 2730 to overlap a least a portion of the distal end of thestretch-valve tube 2820. In this manner, opposing portions of the outersurface of the distal end of the stretch-valve tube 2820 at the distalport 2760 are exposed, one exposed to the interior of the balloon 2810and one exposed to the drainage lumen 2712 but there is no fluidcommunication between either the inflation lumen 2722 or the drainagelumen 2712 and the distal port 2760. To secure the stretch-valve tube2820 in the catheter 2700, the proximal port 2750 is filled with amaterial that fixes the proximal end of the stretch-valve tube 2820 toat least one of the outer wall 2740 and the inflation lumen wall 2720.In one exemplary embodiment, an adhesive bonds the proximal end of thestretch-valve tube 2820 to both the outer wall 2740 and the inflationlumen wall 2720. In the exemplary embodiment, the adhesive can be thesame material as any or all of the walls 2710, 2720, 2730, 2740 or itcan be a different material. If the outer wall 2740 is formed by adipping of the interior parts into a liquid bath of the same materialas, for example, a dual lumen extrusion including the inner wall 2710and the inflation lumen wall 2720, then, when set, the outer wall 2740will be integral to both the inner wall 2710 and the inflation lumenwall 2720 and will be fixedly connected to the stretch-valve tube 2820through the proximal port 2750.

In such a configuration, therefore, any proximal movement of thecatheter 2700 at or proximal to the proximal port 2750 will also movethe stretch-valve tube 2820 proximally; in other words, the distal endof the stretch-valve tube 2820 can slide S within the inflation lumen2722 in a proximal direction. FIG. 29 illustrates how the slide-valve ofthe invention operates when the proximal end of the catheter 2700 ispulled to a force that is no greater than just before injury would occurto the bladder-urethral junction or the urethra if the catheter 2700 wasstill inflated when the force was imparted. In an exemplary embodimentof the stretch valve of FIGS. 27 to 29 , a pulling force in a range of 1to 15 pounds will cause the stretch-valve tube 2820 to slide proximallyS to place the distal end of the stretch-valve tube 2820 just proximalof the distal port 2760, i.e., the deflation point of the stretch-valveshown in FIG. 29 . In another exemplary embodiment, the range of forcerequired to meet the deflation point is between 1 and 5 pounds, inparticular, between 1.5 and 2 pounds.

As can be seen in FIG. 29 , when the deflation point of thestretch-valve is reached, the interior of the balloon 2810 becomesfluidically connected to both the upper and lower portions of the distalport 2760 in a direct and straight line. Because the distal port 2760 isopen to the drainage lumen 2712 (which is open the interior of thebladder 2020 and to the non-illustrated, proximal drain bag) and due tothe fact that the bladder is relatively unpressurized as compared to theballoon 2810, all internal pressure is released from the balloon 2810 toeject the inflating fluid 2200 into the drainage lumen 2712 (depicted bydashed arrows in FIG. 29 ), thereby causing the balloon 2810 to deflaterapidly (depicted by solid opposing arrows). Unlike the embodimentsabove, the distance X between the deflation port (the upper part ofdistal port 2760) and the lower part of distal port 2760 iszero—therefore, the rate at which the balloon 2510 deflates cannot bemade any faster (other than expanding the area of the distal port 2760).It is further noted that the inflation port 2724 also becomesfluidically connected to the drain lumen 2712 and, therefore, drainageof the fluid 2200 occurs through the inflation port 2724 as well (alsodepicted by a dashed arrow). The cross-sectional area of the inflationlumen 2722 only slightly impacts the rate of balloon deflation, if atall. One way to speed up deflation can be to shape the distal port 2760in the form of a funnel outwardly expanding in a direction from theouter circumference of the catheter 2700 inwards towards the drainagelumen 2712. Another way to speed up deflation can be to have two or moreinflation lumens 2722 about the circumference of the inner lumen wall2710 and to have corresponding sets of a stretch-valve tube 2820, aproximal port 2750, and a distal port 2760 for each inflation lumen2722.

FIG. 30 reproduces FIG. 27 to assist in explaining FIGS. 31 and 32 onthe same page. FIGS. 31 and 32 show, respectively, the closed and openedpositions of the stretch-valve tube 2820 in FIGS. 28 and 29 . Thesefigures are viewed in an orientation turned ninety degreescounterclockwise with regard to a central, longitudinal axis of thecatheter 2700 viewed along the axis towards the distal end from theproximal end so that the view looks down upon the distal port 2760. Ascan be seen, without pulling on the proximal end of the catheter 2700(FIG. 31 ), the stretch-valve tube 2820 blocks the distal port 2760.With a proximal force on the proximal end of the catheter 2700, as shownin the orientation of FIG. 32 , the stretch-valve tube 2820 slides andno longer blocks the distal port 2760.

FIGS. 33 to 36 show alternative exemplary embodiments for theautomatically deflating, stretch-valve, safety balloon catheteraccording to the invention. Where various parts of the embodiments arenot described with regard to these figures (e.g., the balloon interiorwall), the above-mentioned parts are incorporated by reference hereininto these embodiments and are not repeated for reasons of brevity.

FIG. 33 illustrates the balloon portion of the inventive catheter 3300with the balloon 3302 in a partially inflated state. An annular innerlumen wall 3310 defines therein a drainage lumen 3312. At one or morecircumferential longitudinal extents about the inner lumen wall 3310, aninflation lumen wall 3320 defines an inflation lumen 3322 and a ballooninflation port 3324 fluidically connected to the inflation lumen 3322;in the inventive catheter, there can be more than one inflation lumen3322 and corresponding inflation port 3324 even though only one is shownherein. Accordingly, the views of FIGS. 33 to 36 show a cross-sectionthrough the single inflation lumen and single inflation port. No lumenplug closes the inflation lumen 3322 distal of the inflation port 3324(this is in contrast to the above-described exemplary embodiments). Inthe exemplary embodiment of FIG. 33 , a stretch-valve mechanism 3330serves to plug the inflation lumen 3322 distal of the inflation port3324 as described in further detail below. An outer wall 3340 covers allof the interior walls 3310 and 3320 in a fluid-tight manner and formsthe exterior of the balloon 3342 but does not cover the distal end ofthe inflation lumen 3322. The outer wall 3340 is formed in any waydescribed herein and is not discussed in further detail here.

The stretch-valve mechanism 3330 is disposed in the inflation lumen 3322to not hinder inflation of the balloon 3302 with inflating fluid. Aproximal, hollow anchor portion 3332 is disposed in the inflation lumen3320 proximal of the inflation port 3324. While the diameter of thehollow anchor portion 3332 can be any size that accommodatessubstantially unhindered fluid flow through the inflation lumen 3322,one exemplary inner diameter of the hollow anchor portion 3332 issubstantially equal to the diameter of the inflation lumen 3322 and theouter diameter of the hollow anchor portion 3332 is just slightly largerthan the diameter of the inflation lumen 3322 (e.g., the wall thicknessof the tube can be between 0.05 mm and 0.2 mm). The longitudinal lengthof the hollow anchor portion 3332 is as long as desired to belongitudinally fixedly secured within the inflation lumen 3322 wheninstalled in place. The tube, from its shape alone, can provide thesecuring connection but, also, an adhesive can be used in any manner,one of which includes creating a proximal port as shown in the aboveembodiments and utilizing the dipped exterior to form the fixedconnection. The distal end of the hollow anchor portion 3332 in thisexemplary embodiment is proximal of a proximal end of the balloon 3302.The distal end of the hollow anchor portion 3332 can be nearer to theinflation port 3324, but not at or distal of the inflation port 3324;both ends of the hollow anchor portion 3332 can be proximal, at, ordistal to the proximal end of the balloon 3302 and selection of thisposition is dependent upon the amount of stretch that is desired toactuate the stretch-valve of the inventive catheter 3300 as describedbelow. In the exemplary embodiment of FIG. 33 , the stretch-valvemechanism 3330 also includes an intermediate stopper wire 3334 connectedat its proximal end to the hollow anchor portion 3332 and a stopper 3336connected to the distal end of the stopper wire 3334. The stopper 3336is sized to be slidably disposed in the inflation lumen 3322 while, atthe same time, to provide a fluid-tight seal so that liquid cannot passfrom one side of the stopper 3336 to the other side within the inflationlumen 3322. The stopper 3336 is located distal of the inflation port3324. The stopper wire 3334, therefore, spans the inflation port 3324.Because the stopper 3336 must traverse the inflation port 3324, it mustbe just distal of the inflation port 3324, but the hollow anchor portioncan be located anywhere proximal of the inflation port 3324. While thelength of the stopper wire 3334 needs to be sufficient to span theinflation port 3324, it can be as long as desired, which will depend onwhere the hollow anchor portion 3332 resides as well as the amount ofstretch desired. As the catheter 3300 stretches more at its proximal endand less at its distal end when pulled from the proximal end, the hollowanchor portion 3322 can be further proximal in the inflation lumen 3322than shown, and can even be very close to or at the proximal end of theinflation lumen 3322. Even though the term “wire” is used herein, thisdoes not necessarily mean that the wire structure is an incompressiblerod. It can, likewise, be a flexible but non-stretchable cable or cord.In such a configuration, therefore, once the stopper 3336 is pulledproximally (to the right in FIG. 33 ), it will not be forced backdistally once the stretching of the catheter is released. As such, theflexible cable embodiment provides a single-actuation valve.

In such a configuration, therefore, any proximal movement of thecatheter 3300 at or proximal to the inflation port 3324 will also movethe stretch-valve mechanism 3330 proximally; in other words, the stopper3336 slides proximally within the inflation lumen 3322 from distal ofthe inflation port 3324 to a proximal side of the inflation port 3324.When the proximal end of the catheter 3300 is pulled to move the stopper3336 across the inflation port 3324 with a force that is no greater thanjust before injury would occur to the bladder-urethral junction or theurethra if the catheter 3300 was still inflated when the force wasimparted, fluid in the balloon 3342 can exit distally out the inflationlumen 3322. In an exemplary embodiment of the stretch valve of FIG. 33 ,a pulling force in a range of 1 to 15 pounds will cause thestretch-valve mechanism 3330 to slide proximally to place the stopper3336 just proximal of the inflation port 3324, i.e., the deflation pointof the stretch-valve shown in FIG. 33 . In another exemplary embodiment,the range of force required to meet the deflation point is between 1 and5 pounds, in particular, between 1.5 and 2 pounds. When the stopper 3336traverses the inflation port 3324, the balloon 3342 automaticallydeflates and the inflating fluid exits into the bladder out the distalend of the inflation lumen 3332, which is open at the distal end of thecatheter 3300.

FIG. 34 illustrates the balloon portion of the inventive catheter 3400with the balloon 3402 in a partially inflated state. An annular innerlumen wall 3410 defines therein a drainage lumen 3412. At one or morecircumferential longitudinal extents about the inner lumen wall 3410, aninflation lumen wall 3420 defines an inflation lumen 3422 and a ballooninflation port 3424 fluidically connected to the inflation lumen 3422;in the inventive catheter, there can be more than one inflation lumen3422 and corresponding inflation port 3424 even though only one is shownherein. No lumen plug closes the inflation lumen 3422 distal of theinflation port 3424. In this exemplary embodiment, a stretch-valvemechanism 3430 serves to plug the inflation lumen 3422 distal of theinflation port 3424 as described in further detail below. An outer wall3440 covers all of the interior walls 3410 and 3420 in a fluid-tightmanner and forms the exterior of the balloon 3442 but does not cover thedistal end of the inflation lumen 3422. The outer wall 3440 is formed inany way described herein and is not discussed in further detail here.

The stretch-valve mechanism 3430 is disposed in the inflation lumen 3422and does not hinder inflation of the balloon 3402 with inflating fluid.A proximal, hollow anchor portion 3432 is disposed in the inflationlumen 3420 proximal of the inflation port 3424. While the diameter ofthe hollow anchor portion 3432 can be any size that accommodatessubstantially unhindered fluid flow through the inflation lumen 3422,one exemplary inner diameter of the hollow anchor portion 3432 issubstantially equal to the diameter of the inflation lumen 3422 and theouter diameter of the hollow anchor portion 3432 is just slightly largerthan the diameter of the inflation lumen 3422 (e.g., the wall thicknessof the tube can be between 0.05 mm and 0.2 mm). Another exemplaryembodiment of the hollow anchor portion 3432 and a stopper 3436 has oneor more of these larger in outer diameter than an intermediate hollowstopper tube 3434. Thus, if one end is larger, the stretch-valvemechanism 3430 has a “club” shape and, if both ends are larger, thestretch-valve mechanism 3430 has a “dumbbell” shape. An exemplaryconfiguration of a dumbbell shaped stretch-valve tube is describedhereinbelow.

The longitudinal length of the hollow anchor portion 3432 is as long asdesired to be longitudinally fixedly secured within the inflation lumen3422 when installed in place. The tube, from its shape alone, canprovide the securing connection but, also, an adhesive can be used inany manner, one of which includes creating a proximal port as shown inthe above embodiments and utilizing the dipped exterior to form thefixed connection. The distal end of the hollow anchor portion 3432 inthis exemplary embodiment is at a proximal side of the balloon 3402. Thedistal end of the hollow anchor portion 3432 can be nearer to theinflation port 3424, but not at or distal of the inflation port 3424;both ends of the hollow anchor portion 3432 can be proximal, at, ordistal to the proximal end of the balloon 3402 and selection of thisposition is dependent upon the amount of stretch that is desired toactuate the stretch-valve of the inventive catheter 3400 as describedbelow. In the exemplary embodiment of FIG. 34 , the intermediate hollowstopper tube 3434 is connected at its proximal end to the hollow anchorportion 3432 and the stopper 3436 is connected to the distal end of thestopper tube 3434. The stopper tube 3434 is only a circumferentialportion of the hollow anchor portion 3432 and is located opposite theinflation port 3424 so that it does not obstruct fluid flow through theinflation port 3424. The stopper 3436, in contrast, is a solid cylinderhaving the same or different outer diameter as the hollow anchor portion3432. The entire mechanism 3430 is sized to be slidably disposed in theinflation lumen 3422 while, at the same time, to provide a fluid-tightseal at the stopper 3436 so that liquid cannot pass from one side of thestopper 3436 to the other side within the inflation lumen 3422. Thestopper 3436 is located distal of the inflation port 3424. The stoppertube 3434, therefore, spans the inflation port 3424. Because the stopper3436 must traverse the inflation port 3424, it must be just distal ofthe inflation port 3424 but the hollow anchor portion 3432 can belocated anywhere proximal of the inflation port 3424. While the lengthof the stopper tube 3434 needs to be sufficient to span the inflationport 3424, it can be as long as desired, which will depend on where thehollow anchor portion 3432 resides. As the catheter 3400 stretches moreat its proximal end and less at its distal end when pulled from theproximal end, the hollow anchor portion 3422 can be further proximal inthe inflation lumen 3422 than shown, and can even be very close to or atthe proximal end of the inflation lumen 3422.

In such a configuration, therefore, any proximal movement of thecatheter 3400 at or proximal to the inflation port 3424 will also movethe stretch-valve mechanism 3430 proximally; in other words, the stopper3436 slides proximally within the inflation lumen 3422 from distal ofthe inflation port 3424 to a proximal side of the inflation port 3424.When the proximal end of the catheter 3400 is pulled to move the stopper3436 across the inflation port 3424 with a force that is no greater thanjust before injury would occur to the bladder-urethral junction or theurethra if the catheter 3400 was still inflated when the force wasimparted, fluid in the balloon 3442 can exit distally out the inflationlumen 3422. In an exemplary embodiment of the stretch valve of FIG. 34 ,a pulling force in a range of 1 to 15 pounds will cause thestretch-valve mechanism 3430 to slide proximally to place the stopper3436 just proximal of the inflation port 3424, i.e., the deflation pointof the stretch-valve shown in FIG. 34 . In another exemplary embodiment,the range of force required to meet the deflation point is between 1 and5 pounds, in particular, between 1.5 and 2 pounds. When the stopper 3436traverses the inflation port 3424, the balloon 3442 automaticallydeflates and the inflating fluid exits into the bladder out the distalend of the inflation lumen 3432, which is open at the distal end of thecatheter 3400.

FIG. 35 illustrates the balloon portion of the inventive catheter 3500with the balloon 3502 in a partially inflated state. An annular innerlumen wall 3510 defines therein a drainage lumen 3512. At one or morecircumferential longitudinal extents about the inner lumen wall 3510, aninflation lumen wall 3520 defines an inflation lumen 3522 and a ballooninflation port 3524 fluidically connected to the inflation lumen 3522;in the inventive catheter, there can be more than one inflation lumen3522 and corresponding inflation port 3524 even though only one is shownherein. No lumen plug closes the inflation lumen 3522 distal of theinflation port 3524. In this exemplary embodiment, a stretch-valvemechanism 3530 serves to plug the inflation lumen 3522 distal of theinflation port 3524 as described in further detail below. An outer wall3540 covers all of the interior walls 3510 and 3520 in a fluid-tightmanner and forms the exterior of the balloon 3542 but does not cover thedistal end of the inflation lumen 3522. The outer wall 3540 is formed inany way described herein and is not discussed in further detail here.

The stretch-valve mechanism 3530 is disposed in the inflation lumen 3522to not hinder inflation of the balloon 3502 with inflating fluid. Aproximal, hollow anchor portion 3532 is disposed in the inflation lumen3520 proximal of the inflation port 3524. While the diameter of thehollow anchor portion 3532 can be any size that accommodatessubstantially unhindered fluid flow through the inflation lumen 3522,one exemplary inner diameter of the hollow anchor portion 3532 issubstantially equal to the diameter of the inflation lumen 3522 and theouter diameter of the hollow anchor portion 3532 is just slightly largerthan the diameter of the inflation lumen 3522 (e.g., the wall thicknessof the tube can be between 0.05 mm and 0.2 mm). Another exemplaryembodiment of the hollow anchor portion 3532 and a stopper 3536 has oneor more of these larger in outer diameter than an intermediate biasdevice 3534. Thus, if one end is larger, the stretch-valve mechanism3430 has a “club” shape and, if both ends are larger, the stretch-valvemechanism 3430 has a “dumbbell” shape. An exemplary configuration of adumbbell shaped stretch-valve tube is described hereinbelow.

The longitudinal length of the hollow anchor portion 3532 is as long asdesired to be longitudinally fixedly secured within the inflation lumen3522 when installed in place. The tube, from its shape alone, canprovide the securing connection but, also, an adhesive can be used inany manner, one of which includes creating a proximal port as shown inthe above embodiments and utilizing the dipped exterior to form thefixed connection. The distal end of the hollow anchor portion 3532 inthis exemplary embodiment is at a proximal side of the balloon 3502. Thedistal end of the stretch-valve mechanism 3530 can be nearer to theinflation port 3524, but not at or distal of the inflation port 3524;both ends of the hollow anchor portion 3532 can be proximal, at, ordistal to the proximal end of the balloon 3502 and selection of thisposition is dependent upon the amount of stretch that is desired toactuate the stretch-valve of the inventive catheter 3500 as describedbelow. In the exemplary embodiment of FIG. 35 , the intermediate biasdevice 3534, such as a spring, is connected at its proximal end to thehollow anchor portion 3532 and the stopper 3536 is connected to thedistal end of the bias device 3534. The bias device 3534 is located atthe inflation port 3524 but not to obstruct fluid flow through theinflation port 3524. The stopper 3536, in contrast, is a solid cylinderhaving the same outer diameter as the hollow anchor portion 3532. Theentire mechanism 3530 is sized to be slidably disposed in the inflationlumen 3522 while, at the same time, to provide a fluid-tight seal at thestopper 3536 so that liquid cannot pass from one side of the stopper3536 to the other side within the inflation lumen 3522. The stopper 3536is located distal of the inflation port 3524. To prevent distal movementof the stopper 3536, a restrictor 3538 is provided distal of the stopper3536. The bias device 3534, therefore, spans the inflation port 3524.Because the stopper 3536 must traverse the inflation port 3524, it mustbe just distal of the inflation port 3524 but the hollow anchor portion3532 can be located anywhere proximal of the inflation port 3524. Whilethe length of the bias device 3534 needs to be sufficient to span theinflation port 3524, it can be as long as desired, which will depend onwhere the hollow anchor portion 3532 resides. As the catheter 3500stretches more at its proximal end and less at its distal end whenpulled from the proximal end, the hollow anchor portion 3522 can befurther proximal in the inflation lumen 3522 than shown, and can even bevery close to or at the proximal end of the inflation lumen 3522.

In such a configuration, therefore, any proximal movement of thecatheter 3500 at or proximal to the inflation port 3524 will also movethe stretch-valve mechanism 3530 proximally; in other words, the stopper3536 slides proximally within the inflation lumen 3522 from distal ofthe inflation port 3524 to a proximal side of the inflation port 3524.When the proximal end of the catheter 3500 is pulled to move the stopper3536 across the inflation port 3524 with a force that is no greater thanjust before injury would occur to the bladder-urethral junction or theurethra if the catheter 3500 was still inflated when the force wasimparted, fluid in the balloon 3542 can exit distally out the inflationlumen 3522. In an exemplary embodiment of the stretch valve of FIG. 35 ,a pulling force in a range of 1 to 15 pounds will cause thestretch-valve mechanism 3530 to slide proximally to place the stopper3536 just proximal of the inflation port 3524, i.e., the deflation pointof the stretch-valve shown in FIG. 35 . In another exemplary embodiment,the range of force required to meet the deflation point is between 1 and5 pounds, in particular, between 1.5 and 2 pounds. When the stopper 3536traverses the inflation port 3524, the balloon 3542 automaticallydeflates and the inflating fluid exits into the bladder out the distalend of the inflation lumen 3532, which is open at the distal end of thecatheter 3500.

FIG. 36 illustrates the balloon portion of the inventive catheter 3600with the balloon 3602 in a partially inflated state. An annular innerlumen wall 3610 defines therein a drainage lumen 3612. At one or morecircumferential longitudinal extents about the inner lumen wall 3610, aninflation lumen wall 3620 defines an inflation lumen 3622 and a ballooninflation port 3624 fluidically connected to the inflation lumen 3622;in the inventive catheter, there can be more than one inflation lumen3622 and corresponding inflation port 3624 even though only one is shownherein. No lumen plug closes the inflation lumen 3622 distal of theinflation port 3624. In this exemplary embodiment, a stretch-valvemechanism 3630 serves to plug the inflation lumen 3622 distal of theinflation port 3624 as described in further detail below. An outer wall3640 covers all of the interior walls 3610 and 3620 in a fluid-tightmanner and forms the exterior of the balloon 3642 but does not cover thedistal end of the inflation lumen 3622. The outer wall 3640 is formed inany way described herein and is not discussed in further detail here.

The stretch-valve mechanism 3630 is disposed in the inflation lumen 3622to not hinder inflation of the balloon 3602 with inflating fluid. Anon-illustrated proximal anchor is disposed in the inflation lumen 3620proximal of the inflation port 3624. The proximal anchor can be any sizeor shape that accommodates unhindered fluid flow through the inflationlumen 3622, one exemplary inner diameter of the hollow anchor portion isa tube substantially equal to the diameter of the inflation lumen 3622with an outer diameter just slightly larger than the diameter of theinflation lumen 3622 (e.g., the thickness of the tube can be between0.07 mm and 0.7 mm). The longitudinal length of this hollow anchor canbe as long as desired to be longitudinally fixedly secured within theinflation lumen 3622 when installed in place. The anchor in thisexemplary embodiment is at or near the non-illustrated proximal end ofthe inflation lumen 3622. The distal end of the stretch-valve mechanism3630 is distal of the inflation port 3624. In the exemplary embodimentof FIG. 36 , the stretch-valve mechanism 3630 also includes anintermediate cord 3634, either inelastic or elastic, connected at itsproximal end to the anchor. A stopper 3636 is connected to the distalend of the cord 3634. The cord 3634 is located at the inflation port3624 but not to obstruct fluid flow through the inflation port 3624. Thestopper 3636, in contrast, is a solid cylinder having a diameter thatallows it to slidably move within the inflation lumen 3622 when the cord3634 pulls it but, at the same time, to provide a fluid-tight seal sothat liquid cannot pass from one side of the stopper 3636 to the otherside within the inflation lumen 3622. The stopper 3636 is located distalof the inflation port 3624. To prevent distal movement of the stopper3636, a restrictor 3638 is provided distal of the stopper 3636. The cord3634, therefore, spans the inflation port 3624. Because the stopper 3636must traverse the inflation port 3624, it must be just distal of theinflation port 3624 but the anchor can be located anywhere proximal ofthe inflation port 3624. While the length of the cord 3634 needs to besufficient to span the inflation port 3624, it can be as long asdesired, which will depend on where the anchor resides. As the catheter3600 stretches more at its proximal end and less at its distal end whenpulled from the proximal end, the anchor can be very close to or at theproximal end of the inflation lumen 3622. It can even be attached to theluer connector half that prevents fluid from flowing out the proximalend of the inflation lumen 3622.

In such a configuration, therefore, any proximal movement of thecatheter 3600 at the proximal end where the anchor resides will alsomove the stretch-valve mechanism 3630 proximally; in other words, thestopper 3636 slides proximally within the inflation lumen 3622 fromdistal of the inflation port 3624 to a proximal side of the inflationport 3624. When the proximal end of the catheter 3600 is pulled to movethe stopper 3636 across the inflation port 3624 with a force that is nogreater than just before injury would occur to the urethrovesicaljunction or the urethra if the catheter 3600 was still inflated when theforce was imparted, fluid in the balloon 3642 can exit distally out theinflation lumen 3622. In an exemplary embodiment of the stretch valve ofFIG. 36 , a pulling force in a range of 1 to 15 pounds will cause thestretch-valve mechanism 3630 to slide proximally to place the stopper3636 just proximal of the inflation port 3624, i.e., the deflation pointof the stretch-valve shown in FIG. 36 . In another exemplary embodiment,the range of force required to meet the deflation point is between 1 and5 pounds, in particular, between 1.5 and 2 pounds. When the stopper 3636traverses the inflation port 3624, the balloon 3642 automaticallydeflates and the inflating fluid exits into the bladder out the distalend of the inflation lumen 3622, which is open at the distal end of thecatheter 3600.

An alternative exemplary embodiment combines the embodiments of FIGS. 30and 36 to tether the tube 2820 to the proximal end of the catheter.

In each of the embodiments of FIGS. 33 to 36 , deflation of the balloon3342, 3442, 3542, 3642 out through the inflation lumen 3322, 3422, 3522,3622 can be enhanced by creating a separate deflation port D between thestopper 3336, 3436, 3536, 3636 and the drain lumen 3312, 3412, 3512,3612 at the rest or steady state position of the stopper 3336, 3436,3536, 3636 (shown in FIGS. 33 to 36 ). In such a configuration, when thestopper 3336, 3436, 3536, 3636 moves downstream of the inflation port3324, 3424, 3524, 3624, not only will the inflation fluid exit thedistal (upstream) end of the inflation lumen 3322, 3422, 3522, 3622, butit will also exit directly into the drain lumen 3312, 3412, 3512, 3612.It is noted that, when the stopper 3336, 3436, 3536, 3636 moves onlyslightly downstream but not at or past the inflation port 3324, 3424,3524, 3624, the deflation port D will connect the drain lumen 3312,3412, 3512, 3612 to the inflation lumen 3322, 3422, 3522, 3622fluidically. This is not disadvantageous in in these configurationsbecause these lumens will be connected already through the distal endsthereof in the drainage organ (e.g., the bladder).

FIG. 37 illustrates the balloon portion of the inventive catheter 3700with the balloon 3742 in a partially inflated state. An annular innerlumen wall 3710 defines therein a drainage lumen 3712. At one or morecircumferential longitudinal extents about the inner lumen wall 3710, aninflation lumen wall 3720 defines an inflation lumen 3722 and a ballooninflation port 3724 fluidically connected to the inflation lumen 3722;in the inventive catheter, there can be more than one inflation lumen3722 and corresponding inflation port 3724 even though only one is shownherein. A lumen plug 3736 fluidically closes the inflation lumen 3722distal of the inflation port 3724 so that all inflation fluid 3702 isdirected into the balloon 3742. The lumen plug 3736 can plug any pointor extent from the inflation port 3724 distally. An outer wall 3740covers all of the interior walls 3710 and 3720 in a fluid-tight mannerand forms the exterior of the balloon 3742 but does not cover the distalend of the drainage lumen 3712. The outer wall 3740 is formed in any waydescribed herein and is not discussed in further detail here.

In this exemplary embodiment, a hollow, stretch-valve tube 3730 isdisposed in the drainage lumen 3712 to not hinder drainage of the fluidto be drained (e.g., urine). While the diameter of the stretch-valvetube 3730 can be any size that accommodates substantially unhinderedfluid flow through the drainage lumen 3712, one exemplary inner diameterof the stretch-valve tube 3730 is substantially equal to the diameter ofthe drainage lumen 3712 and the outer diameter of the stretch-valve tube3730 is just slightly larger than the diameter of the drainage lumen3712 (e.g., the wall thickness of the tube can be between 0.07 mm and0.7 mm). Another exemplary embodiment of the stretch-valve tube 3730 hasone or more of the proximal and distal ends thereof larger in outerdiameter than an intermediate portion of the stretch-valve tube 3730.Thus, if one end is larger, the stretch-valve tube 3730 has a “club”shape and, if both ends are larger, the stretch-valve tube 3730 has a“dumbbell” shape. An exemplary configuration of a dumbbell shapedstretch-valve tube is described hereinbelow.

The proximal end of the stretch-valve tube 3730 in this exemplaryembodiment is proximal of a proximal end of a deflation port 3760. Thedistal end of the stretch-valve tube 3730 is not distal of the distalend of the balloon 3742 so that the balloon 3742 can be deflated; thedistal end can be anywhere between the two ends of the balloon 3742 butis shown in an intermediate position in FIG. 37 . The distal end of thestretch-valve tube 3730 is at a distance S distal of the deflation port3760 and selection of this distance S is dependent upon the amount ofstretch required to actuate the stretch-valve of the inventive catheter3700 as described below. In the exemplary embodiment of FIG. 37 , thelongitudinal length of the deflation port 3760 is shown as less than onehalf of the longitudinal length of the stretch-valve tube 3730. Thedeflation port 3760 is formed through the inner lumen wall 3710 and thestretch-valve tube 3730 is positioned to overlap at least the deflationport 3760. In this manner, a portion of the outer surface of the distalend of the stretch-valve tube 3730 closes off the deflation port 3760 toprevent fluid communication between the balloon 3742 and the drainagelumen 3712 through the deflation port 3760.

Exemplary embodiments for securing the stretch-valve tube 3730 in thecatheter 3700 include a proximal anchor 3732 in the drainage lumen 3710disposed away from the deflation port 3760, here proximally. Theproximal anchor 3732 can be any size or shape that accommodatessubstantially unhindered fluid flow through the drainage lumen 3712, oneexemplary inner diameter of the hollow anchor 3732 being a tube or ringsubstantially equal to the diameter of the drainage lumen 3712 with anouter diameter just slightly larger than the diameter of the drainagelumen 3712 (e.g., the thickness of the tube can be between 0.07 mm and0.7 mm). The longitudinal length of this hollow anchor 3732 can be aslong as desired but just enough to longitudinally fixedly secure thestretch-valve tube 3730 within the drainage lumen 3712 when installed inplace. The anchor 3732 in this exemplary embodiment is at the proximalend of the balloon 3742 but can be further inside the balloon 3742(distal) or entirely proximal of the balloon 3742. In an exemplaryembodiment, the anchor 3732 has a stepped distal orifice that permitsthe proximal end of the stretch-valve tube 3730 to be, for example,press-fit therein for permanent connection. In another exemplaryembodiment, the anchor 3732 is an adhesive or glue that fixes theproximal end of the stretch-valve tube 3730 longitudinally in placewithin the drainage lumen 3712. The adhesive can be the same material asany or all of the walls 3710, 3720, 3740 or it can be a differentmaterial. In an exemplary non-illustrated embodiment where a fixationport or set of fixation ports are formed through the inner wall 3710proximal of the proximal-most end of the balloon 3742 and about theproximal end of the stretch-valve tube 3730, if the outer wall 3740 isformed by a dipping of the interior parts into a liquid bath of the samematerial as, for example, a dual lumen extrusion including the innerwall 3710 and the inflation lumen wall 3720, then, when set, the outerwall 3740 will be integral to both the inner wall 3710 and the inflationlumen wall 3720 and will be fixedly connected to the stretch-valve tube3730 through the fixation port(s). (Further exemplary embodiments forsecuring the stretch-valve tube 3730 in the catheter 3700 are describedbelow with regard to FIGS. 48 to 56 .)

In such a configuration, therefore, any proximal movement of thecatheter 3700 at or proximal to the deflation port 3760 will also movethe stretch-valve tube 3730 proximally; in other words, the distal endof the stretch-valve tube 3730 can slide within the drainage lumen 3712in a proximal direction. When the proximal end of the catheter 3700 ispulled to a force that is no greater than just before injury would occurto the bladder-urethral junction or to the urethra if the catheter 3700was still inflated when the force was imparted, the force will cause thestretch-valve tube 3730 to slide proximally and place the distal end ofthe stretch-valve tube 3730 just proximal of the deflation port 3760,e.g., with a pulling force in a range of 1 to 15 pounds. In anotherexemplary embodiment, the range of force required to meet the deflationpoint is between 1 and 5 pounds, in particular, between 1.5 and 2pounds.

When the deflation point of the stretch-valve tube 3730 occurs, theinterior of the balloon 3742 becomes fluidically connected directly intothe drainage lumen 3712 (which is open to the interior of the bladder2020 and to the non-illustrated, proximal drain bag) and, due to thefact that the bladder is relatively unpressurized as compared to theballoon 3742, all internal pressure is released from the balloon 3742 toeject the inflating fluid 3702 directly into the drainage lumen 3712,thereby causing the balloon 3742 to deflate rapidly. Because there is nointermediate structure between the balloon inflating fluid 3702 and thedrainage lumen 3712, the rate at which the balloon 3742 deflates isfast. One way to speed up deflation can be to shape the deflation port3760 in the form of a funnel outwardly expanding in a direction from theouter wall 3740 towards the interior of the catheter 3700. Another wayto speed up deflation can be the presence of two or more deflation ports3760 about the circumference of the inner lumen wall 3710 and/or anenlargement of the cross-sectional area of the deflation port 3760.

FIG. 38 illustrates a balloon portion of the inventive catheter 3800with a balloon 3842 in a partially inflated state. An annular innerlumen wall 3810 defines therein a drainage lumen 3812. At one or morecircumferential longitudinal extents about the inner lumen wall 3810, aninflation lumen wall 3820 defines an inflation lumen 3822 and a ballooninflation port 3824 fluidically connected to the inflation lumen 3822;in the inventive catheter, there can be more than one inflation lumen3822 and corresponding inflation port 3824 even though only one is shownherein. A lumen plug 3836 fluidically closes the inflation lumen 3822distal of the inflation port 3824 so that all inflation fluid 3802 isdirected into the balloon 3842. The lumen plug 3736 can plug any pointor extent from the inflation port 3724 distally. An outer wall 3840covers all of the interior walls 3810 and 3820 in a fluid-tight mannerand forms the exterior of the balloon 3842 but does not cover the distalend of the drainage lumen 3812. The outer wall 3840 is formed in any waydescribed herein and is not discussed in further detail here.

In this exemplary embodiment, a hollow, stretch-valve tube 3830 isdisposed in the drainage lumen 3812 to not hinder drainage of the fluidto be drained (e.g., urine). While the diameter of the stretch-valvetube 3830 can be any size that accommodates substantially unhinderedfluid flow through the drainage lumen 3812, one exemplary inner diameterof the stretch-valve tube 3830 is substantially equal to the diameter ofthe drainage lumen 3812 and the outer diameter of the stretch-valve tube3830 is just slightly larger than the diameter of the drainage lumen3812 (e.g., the wall thickness of the tube can be between 0.07 mm and0.7 mm). Another exemplary embodiment of the stretch-valve tube 3830 hasone or more of the proximal and distal ends thereof larger in outerdiameter than an intermediate portion of the stretch-valve tube 3830.Thus, if one end is larger, the stretch-valve tube 3830 has a “club”shape and, if both ends are larger, the stretch-valve tube 3830 has a“dumbbell” shape. An exemplary configuration of a dumbbell shapedstretch-valve tube is described hereinbelow.

The proximal end of the stretch-valve tube 3830 in this exemplaryembodiment is proximal of a proximal end of a deflation port 3860. Thelongitudinal length of the deflation port 3860 is not distal of thedistal end of the balloon 3842 so that the balloon 3842 can be deflated;the distal end can be anywhere between the two ends of the balloon 3842but is shown in an intermediate position in FIG. 38 . The distal end ofthe stretch-valve tube 3830 is at a distance S distal of the deflationport 3860 and selection of this distance S is dependent upon the amountof stretch required to actuate the stretch-valve of the inventivecatheter 3800 as described below. In the exemplary embodiment of FIG. 38, the longitudinal length of the deflation port 3760 is shown as lessthan one half of the longitudinal length of the stretch-valve tube 3830.The drainage port 3860 is formed through the inner lumen wall 3810 andthe stretch-valve tube 3830 is positioned to overlap at least thedrainage port 3860. In this manner, a portion of the outer surface ofthe distal end of the stretch-valve tube 3830 closes off the drainageport 3860 to prevent fluid communication between the balloon 3842 andthe drainage lumen 3812 through the drainage port 3860.

In this exemplary embodiment, in comparison to the embodiment of FIG. 37, a second drainage port 3862 is provided in the inner lumen wall 3810aligned with the drainage port 3860, and both drainage ports 3860, 3862are aligned with the inflation port 3824. As such, when thestretch-valve tube 3830 moves proximally to uncover the drainage ports3860, 3862, inflation fluid 3802 from inside the balloon 3842 exits fromboth the inflation port 3824 and the drainage port 3860.

To secure the stretch-valve tube 3830 in the catheter 3800, a proximalanchor 3832 is disposed in the drainage lumen 3810 away from thedeflation ports 3860, 3862, here proximally. The proximal anchor 3832can be any size or shape that accommodates substantially unhinderedfluid flow through the drainage lumen 3812, one exemplary inner diameterof the hollow anchor 3832 being a tube or ring substantially equal tothe diameter of the drainage lumen 3812 with an outer diameter justslightly larger than the diameter of the drainage lumen 3812 (e.g., thethickness of the tube can be between 0.07 mm and 0.7 mm). Thelongitudinal length of this hollow anchor 3832 can be as long as desiredbut just enough to longitudinally fixedly secure the stretch-valve tube3830 within the drainage lumen 3812 when installed in place. The anchor3832 in this exemplary embodiment is at the proximal end of the balloon3842 but can be further inside the balloon 3842 (distal) or entirelyproximal of the balloon 3842. In an exemplary embodiment, the anchor3832 has a stepped distal orifice that permits the proximal end of thestretch-valve tube 3830 to be, for example, press-fit therein forpermanent connection. In another exemplary embodiment, the anchor 3832is an adhesive or glue that fixes the proximal end of the stretch-valvetube 3830 longitudinally in place within the drainage lumen 3812. Theadhesive can be the same material as any or all of the walls 3810, 3820,3840 or it can be a different material. In an exemplary non-illustratedembodiment where a fixation port or set of fixation ports are formedthrough the inner wall 3810 proximal of the proximal-most end of theballoon 3842 and about the proximal end of the stretch-valve tube 3830,if the outer wall 3840 is formed by a dipping of the interior parts intoa liquid bath of the same material as, for example, a dual lumenextrusion including the inner wall 3810 and the inflation lumen wall3820, then, when set, the outer wall 3840 will be integral to both theinner wall 3810 and the inflation lumen wall 3820 and will be fixedlyconnected to the stretch-valve tube 3820 through the fixation port(s).(Further exemplary embodiments for securing the stretch-valve tube 3830in the catheter 3800 are described below with regard to FIGS. 48 to 56.)

In such a configuration, therefore, any proximal movement of thecatheter 3800 at or proximal to the drainage ports 3860, 3862 will alsomove the stretch-valve tube 3830 proximally; in other words, the distalend of the stretch-valve tube 3830 can slide within the drainage lumen3812 in a proximal direction. When the proximal end of the catheter 3800is pulled to a force that is no greater than just before injury wouldoccur to the bladder-urethral junction or the urethra if the catheter3800 was still inflated when the force was imparted, the force willcause the stretch-valve tube 3830 to slide proximally to place thedistal end of the stretch-valve tube 3830 just proximal of the drainageports 3860, 3862, e.g., with a pulling force in a range of 1 to 15pounds. In another exemplary embodiment, the range of force required tomeet the deflation point is between 1 and 5 pounds, in particular,between 1.5 and 2 pounds.

When the deflation point of the stretch-valve tube 3830 occurs, theinterior of the balloon 3842 becomes fluidically connected directly intothe drainage lumen 3812 (which is open to the interior of the bladder2020 and to the non-illustrated, proximal drain bag) and, due to thefact that the bladder is relatively unpressurized as compared to theballoon 3842, all internal pressure is released from the balloon 3842 toeject the inflating fluid 3802 directly into the drainage lumen 3812,thereby causing the balloon 3842 to deflate rapidly. Because there is nointermediate structure between the balloon inflating fluid 3802 and thedrainage lumen 3812, the rate at which the balloon 3842 deflates isfast. One way to speed up deflation can be to shape the drainage ports3860, 3862 in the form of a funnel outwardly expanding in a directionfrom the outer wall 3840 towards the interior of the catheter 3800.Another way to speed up deflation can be to have two or more drainageports 3860 about the circumference of the inner lumen wall 3810 and/orto enlarge the cross-sectional area of the drainage ports 3860, 3862.

Reference is made to the flow chart of FIG. 39 to explain one exemplaryembodiment of a process for making a catheter according to theembodiment of FIGS. 21 to 23 .

The catheter starts, in Step 3910 with a dual lumen extrusion of latex.This extrusion, therefore, defines the annular inner lumen wall 2110with the drainage lumen 2112 and, at one or more circumferentiallongitudinal extents about the inner lumen wall 2110, an inflation lumenwall 2120 with the inflation lumen 2122. The dual lumen, therefore,already includes both the drainage lumen 2112 and the inflation lumen2122. Both lumen 2112, 2122, however, are extruded without obstructionand without radial ports. Therefore, in order to have the inflation port2124, a radial hole needs to be created between the outside surface ofthe extrusion and the inflation lumen.

In step 3912, the balloon inflation port 2124 is made to fluidicallyconnect the environment of the extrusion to the inflation lumen 2122.

Sealing off of the distal end of the inflation lumen 2122 can beperformed in Step 3914 by inserting or creating a plug 2126 therein orthe sealing can occur simultaneously with the creation of the outer wall2140 below.

In step 3916, a balloon sleeve 2130 is placed about the inflation port2124 and is fixed to the exterior of the inflation lumen wall 2120 atboth ends to define a fluid-tight balloon interior 2200 therebetween. Assuch, inflation of the balloon 2210 can occur through the inflationlumen 2122. For example, the tube 2130 making up the inner balloon wallis slid over the distal end of the dual-lumen extrusion to cover theinflation port 2124 and is fluid-tightly sealed to the inner multi-lumenextrusion at both ends of the tube but not in the intermediate portion.This tube can be made of latex as well and, therefore, can be secured tothe latex multi-lumen extrusion in any known way to bond latex in afluid-tight manner.

In step 3918, the entire sub-assembly is covered with the outer wall2140. For example, the entire sub-assembly is dipped into latex in itsliquid form to create the outer wall 2140. In the alternative embodimentwhere a distal inflation lumen plug is not used, the latex can beallowed to enter at least a portion of the distal end of the inflationlumen 2122 but not so far as to block the inflation port 2124. When thelatex cures, the balloon 2210 is fluid tight and can only be fluidicallyconnected to the environment through the proximal-most opening of theinflation port, which is fluidically connected to the inflation lumen2122. In this process, the inner wall 2110, the inflation lumen wall2120, the plug 2126, the balloon wall 2130, and the outer wall 2140 areall made of the same latex material and, therefore, together form a verysecure water-tight balloon 2210.

The sub-process described in Steps 3910 to 3920 can be skipped ifdesired and, instead, completed by utilizing a standard Foley catheter,on which the following steps are performed.

The stretch valve is now created. A proximal port 2150 is formed throughthe outer wall 2140 and through the inflation lumen wall 2020 in step3920. A distal port 2160 is formed through the outer wall 2140 andthrough the inflation lumen wall 2020 in step 3922. Then, in step 3924,the stretch-valve tube 2220 is inserted through either one of theproximal or distal ports 2150, 2160 such that the proximal port 2150overlaps at least a portion of the proximal end of the stretch-valvetube 2220 and the distal port 2160 overlaps at least a portion of thedistal end of the stretch-valve tube 2220. In this manner, two portionsof the outer surface of the proximal end of the stretch-valve tube 2220at the proximal and distal ports 2150, 2160 are exposed to theenvironment but there is no fluid communication with the inflation lumen2122 and the proximal or distal ports 2150, 2160.

In Step 3926, the proximal port 2150 is used to secure the stretch-valvetube 2220 in the catheter 2100. In one exemplary embodiment, theproximal port 2150 is filled with a material that fixes the proximal endof the stretch-valve tube 2220 to at least one of the outer wall 2140and the inflation lumen wall 2020. In an exemplary embodiment, anadhesive bonds the proximal end of the stretch-valve tube 2220 to boththe outer wall 2140 and the inflation lumen wall 2120. In anotherexemplary embodiment, a portion of the present sub-assembly is dippedinto latex in its liquid form to plug the proximal port 2150 and fixedlysecure the stretch-valve tube 2220 to both the outer wall 2140 and theinflation lumen wall 2120. When the latex cures, the connection at theproximal port 2150 is fluid tight and no longer permits fluidicconnection to the environment therethrough. In this process, therefore,the filled proximal port 2150, the inflation lumen wall 2120, and theouter wall 2140 are all made of the same latex material and, therefore,together form a very secure water-tight connection. (Further exemplaryembodiments for securing the stretch-valve tube 2220 in the catheter2100 are described below with regard to FIGS. 48 to 56 .)

In such a configuration, therefore, any proximal movement of thecatheter 2100 at or proximal of the proximal port 2150 will also movethe stretch-valve tube 2220 proximally; in other words, the distal endof the stretch-valve tube 2220 can slide within the inflation lumen 2122in a proximal direction.

Reference is also made to the flow chart of FIG. 39 to explain oneexemplary embodiment of a process for making a catheter according to theembodiment of FIGS. 24 to 26 .

The catheter starts, in Step 3910 with a dual lumen extrusion of latex.This extrusion, therefore, defines the annular inner lumen wall 2410with the drainage lumen 2412 and, at one or more circumferentiallongitudinal extents about the inner lumen wall 2410, an inflation lumenwall 2420 with the inflation lumen 2422. The dual lumen, therefore,already includes both the drainage lumen 2412 and the inflation lumen2422. Both lumens 2412, 2422, however, are extruded without obstructionand without radial ports. Therefore, in order to have the inflation port2424, a radial hole needs to be created between the outside surface ofthe extrusion and the inflation lumen.

In Step 3912, the balloon inflation port 2424 is made to fluidicallyconnect the environment of the extrusion to the inflation lumen 2422.

Sealing off of the distal end of the inflation lumen 2422 can beperformed in Step 3914 by inserting or creating a plug 2426 therein orthe sealing can occur simultaneously with the creation of the outer wall2440 below.

In Step 3916, a balloon sleeve 2430 is placed about the inflation port2424 and is fixed to the exterior of the inflation lumen wall 2420 atboth ends to define a fluid-tight balloon interior 2200 therebetween. Assuch, inflation of the balloon 2240 can occur through the inflationlumen 2422. For example, the tube 2430 making up the inner balloon wallis slid over the distal end of the dual-lumen extrusion to cover theinflation port 2424 and is fluid-tightly sealed to the inner multi-lumenextrusion at both ends of the tube but not in the intermediate portion.This tube can be made of latex as well and, therefore, can be secured tothe latex multi-lumen extrusion in any known way to bond latex in afluid-tight manner.

In Step 3918, the entire sub-assembly is covered with the outer wall2440. For example, the entire sub-assembly is dipped into latex in itsliquid form to create the outer wall 2440. In the alternative embodimentwhere a distal inflation lumen plug is not used, the latex can beallowed to enter at least a portion of the distal end of the inflationlumen 2422 but not so far as to block the inflation port 2424. When thelatex cures, the balloon 2240 is fluid tight and can only be fluidicallyconnected to the environment through the proximal-most opening of theinflation port, which is fluidically connected to the inflation lumen2422. In this process, the inner wall 2410, the inflation lumen wall2420, the plug 2426, the balloon wall 2430, and the outer wall 2440 areall made of the same latex material and, therefore, together form a verysecure water-tight balloon 2240.

The sub-process described in Steps 3910 to 3920 can be skipped ifdesired and, instead, completed by utilizing a standard Foley catheter,on which the following Steps are performed.

The stretch valve is now created. A proximal port 2450 is formed throughthe outer wall 2440 and through the inflation lumen wall 2020 in Step3920. A distal port 2460 is formed through the inner wall 2410 into theinflation lumen 2422 in Step 3922. Then, in Step 3924, the stretch-valvetube 2520 is inserted through either one of the proximal or distal ports2450, 2460 such that the proximal port 2450 overlaps at least a portionof the proximal end of the stretch-valve tube 2520 and the distal port2460 overlaps at least a portion of the distal end of the stretch-valvetube 2520. In this manner, one portion of the outer surface of theproximal end of the stretch-valve tube 2520 at the proximal port 2450 isexposed to the drain lumen 2412 and another portion of the outer surfaceof the distal end of the stretch-valve tube 2520 at the distal port 2460is exposed to the environment but there is no fluid communication withthe inflation lumen 2422 to either of the proximal or distal ports 2450,2460.

In Step 3926, the proximal port 2450 is used to secure the stretch-valvetube 2520 in the catheter 2400. In one exemplary embodiment, theproximal port 2450 is filled with a material that fixes the proximal endof the stretch-valve tube 2520 to at least one of the outer wall 2440and the inflation lumen wall 2020. In an exemplary embodiment, anadhesive bonds the proximal end of the stretch-valve tube 2520 to boththe outer wall 2440 and the inflation lumen wall 2420. In anotherexemplary embodiment, a portion of the present sub-assembly is dippedinto latex in its liquid form to plug the proximal port 2450 and fixedlysecure the stretch-valve tube 2520 to both the outer wall 2440 and theinflation lumen wall 2420. When the latex cures, the connection at theproximal port 2450 is fluid tight and no longer permits fluidicconnection to the environment therethrough. In this process, therefore,the filled proximal port 2450, the inflation lumen wall 2420, and theouter wall 2440 are all made of the same latex material and, therefore,together form a very secure water-tight connection. (Further exemplaryembodiments for securing the stretch-valve tube 2520 in the catheter2400 are described below with regard to FIGS. 48 to 56 .)

In such a configuration, therefore, any proximal movement of thecatheter 2400 at or proximal of the proximal port 2450 will also movethe stretch-valve tube 2520 proximally; in other words, the distal endof the stretch-valve tube 2520 can slide within the inflation lumen 2422in a proximal direction.

Reference is made to the flow chart of FIG. 40 to explain one exemplaryembodiment of a process for making a catheter according to theembodiment of FIGS. 27 to 29 .

The catheter starts, in Step 4010 with a dual lumen extrusion of latex.This extrusion, therefore, defines the annular inner lumen wall 2710with the drainage lumen 2712 and, at one or more circumferentiallongitudinal extents about the inner lumen wall 2710, an inflation lumenwall 2720 with the inflation lumen 2722. The dual lumen, therefore,already includes both the drainage lumen 2712 and the inflation lumen2722. Both lumen 2712, 2722, however, are extruded without obstructionand without radial ports. Therefore, in order to have the inflation port2724, a radial hole needs to be created between the outside surface ofthe extrusion and the inflation lumen.

In Step 4012, the balloon inflation port 2724 is made to fluidicallyconnect the environment of the extrusion to the inflation lumen 2722.

Different from the other exemplary embodiments described, a distal port2760 is created in Step 4014 before, after, or at the same time as theballoon inflation port 2724. The distal port 2760 connects theenvironment to the interior of the drain lumen 2712. In an exemplaryembodiment, the distal port 2760 is proximal of the balloon inflationport 2724.

Sealing off of the distal end of the inflation lumen 2722 can beperformed in Step 4016 by inserting or creating a plug 2726 therein orthe sealing can occur simultaneously with the creation of the outer wall2740 below.

In Step 4018, a balloon sleeve 2730 is placed about the inflation port2724 and the distal port 2760 and is fixed to the exterior of theinflation lumen wall 2720 at both ends to define a fluid-tight ballooninterior 2200 therebetween. As such, inflation of the balloon 2810 canoccur through the inflation lumen 2722. For example, the tube 2730making up the inner balloon wall is slid over the distal end of thedual-lumen extrusion to cover the inflation port 2724 and isfluid-tightly sealed to the inner multi-lumen extrusion at both ends ofthe tube but not in the intermediate portion. This tube can be made oflatex as well and, therefore, can be secured to the latex multi-lumenextrusion in any known way to bond latex in a fluid-tight manner.

Installation of the stretch valve occurs by forming a proximal port 2750through the inflation lumen wall 2020 in Step 4020. Then, in Step 4022,the stretch-valve tube 2820 is inserted through either one of theproximal or distal ports 2750, 2760 such that the proximal port 2750overlaps at least a portion of the proximal end of the stretch-valvetube 2820 and the distal port 2760 overlaps at least a portion of thedistal end of the stretch-valve tube 2820. In this manner, two portionsof the outer surface of the proximal end of the stretch-valve tube 2820at the proximal and distal ports 2750, 2760 are exposed to theenvironment but there is no fluid communication with the inflation lumen2722 and the proximal or distal ports 2750, 2760. Alternatively, Steps4022 can occur before 4018 to insert the stretch-valve tube 2820 beforethe balloon sleeve 2730 is placed and fixed. In such a case, thecreation of the proximal port 2750 can occur before, after, or at thesame time as creating the distal port 2760 and the balloon inflationport 2724, in which embodiment, all three ports 2724, 2750, 2760 can becreated at the same time.

In Step 4024, the entire sub-assembly is covered with the outer wall2740. For example, the entire sub-assembly is dipped into latex in itsliquid form to create the outer wall 2740. In the alternative embodimentwhere a distal inflation lumen plug is not used, the latex can beallowed to enter at least a portion of the distal end of the inflationlumen 2722 but not so far as to block the inflation port 2724. When thelatex cures, the balloon 2810 is fluid tight and can only be fluidicallyconnected to the environment through the proximal-most opening of theinflation port, which is fluidically connected to the inflation lumen2722. In this process, the inner wall 2710, the inflation lumen wall2720, the plug 2726, the balloon wall 2730, and the outer wall 2740 areall made of the same latex material and, therefore, together form a verysecure water-tight balloon 2810.

In previous embodiments, the proximal port 2750 pierced the outer wall2740. In this exemplary embodiment, however, there is no need to do so.Here, the proximal port 2750 can be filled with material of the outerwall 2740 itself to fix the proximal end of the stretch-valve tube 2820to at least one of the outer wall 2740 and the inflation lumen wall 2020to secure the stretch-valve tube 2820, which occurs in Step 4026. Whenthe latex cures, the connection at the proximal port 2750 is fluid tightand no longer permits fluidic connection to the environmenttherethrough. In this process, therefore, the filled proximal port 2750,the inflation lumen wall 2720, and the outer wall 2740 are all made ofthe same latex material and, therefore, together, form a very securewater-tight connection. In an alternative exemplary embodiment, anadhesive can be used to bond the proximal end of the stretch-valve tube2820 to the inflation lumen wall 2720. (Further exemplary embodimentsfor securing the stretch-valve tube 2820 in the catheter 2700 aredescribed below with regard to FIGS. 48 to 56 .)

In such a configuration, therefore, any proximal movement of thecatheter 2700 at or proximal of the proximal port 2750 will also movethe stretch-valve tube 2820 proximally; in other words, the distal endof the stretch-valve tube 2820 can slide within the inflation lumen 2722in a proximal direction.

Reference is made to the flow chart of FIG. 41 to explain one exemplaryembodiment of a process for making a catheter according to theembodiment of FIGS. 37 and 38 .

The catheter starts, in Step 4110 with a dual lumen extrusion of latex.This extrusion, therefore, defines the annular inner lumen wall 3710,3810 with the drainage lumen 3712, 3812 and, at one or morecircumferential longitudinal extents about the inner lumen wall 3710,3810, an inflation lumen wall 3720, 3820 with the inflation lumen 3722,3822. The dual lumen, therefore, already includes both the drainagelumen 2712, 2812 and the inflation lumen 2722, 2822. Both lumen 2712,2722, 2812, 2822, however, are extruded without obstruction and withoutradial ports. Therefore, in order to have the inflation port 3724, 3824,a radial hole needs to be created between the outside surface of theextrusion and the inflation lumen.

In Step 4112, the balloon inflation port 3724, 3824 is made tofluidically connect the environment of the extrusion to the inflationlumen 3722, 3822.

Different from the other exemplary embodiments described, with regard tothe embodiment of FIG. 37 , the deflation port 3760 is created in Step4114 before, after, or at the same time as the balloon inflation port3724. The deflation port 3760 connects the interior of the balloon 3742to the interior of the drain lumen 3712. In an exemplary embodiment, thedeflation port 3760 is proximal of the balloon inflation port 3724 butcan be at or distal thereof.

Different from the other exemplary embodiments described, with regard tothe embodiment of FIG. 38 , the drainage ports 3860 and 3862 are createdin Step 4114 before, after, or at the same time as the balloon inflationport 3824. The drainage port 3860 connects the interior of the balloon3842 to the interior of the drain lumen 2712 and the drainage port 3862connects the interior of the inflation lumen 3822 to the interior of thedrain lumen 2712. In an exemplary embodiment, the drainage ports 3860,3862 are aligned with the balloon inflation port 3824 but they can bedistal or proximal thereof. When aligned, a single through-hole can bemade through the entire catheter, penetrating both the inflation anddrainage channels 3712, 3722, 3812, 3822 and both walls 3710, 3720,3810, 3820 of the dual lumen extrusion. Alternatively, the drainageports 3860, 3862 can be spaced from one another with either one orneither aligned with the inflation port 3824.

In Step 4116, a fixation point 3732, 3832 is established at the outerwall 3710, 3810. At this fixation point 3732, 3832 are the measures forfixing the stretch-valve tube 3730, 3830 inside the drainage lumen 3712,3812. The fixation point 3732, 3832 can be placed anywhere proximal ofthe drainage ports 3760, 3860, 3862. The fixation point 3732, 3832 isnot aligned circumferentially with the inflation port 3724, 3824 asshown in FIGS. 37 and 38 . In the exemplary embodiment shown, thefixation point 3732, 3832 is still within the proximal end of theballoon 3742, 3842 but it can equally be further proximal of the balloon3742, 3842 to any point proximal within the drainage lumen 3712, 3812.

Sealing off of the distal end of the inflation lumen 3722, 3822 can beperformed in Step 4118 by inserting or creating a plug 3736, 3836therein or the sealing can occur before forming the fixation ports orjust before or simultaneously with the creation of the outer wall 3740,3840 below in Step 4124.

In Step 4120, the stretch-valve tube 3730, 3830 is inserted into thedrainage lumen 3712, 3812 and aligned so that the stretch-valve tube3730, 3830 covers all drainage ports 3760, 3860, 3862. The distal end ofthe stretch-valve tube 3730, 3830 is positioned at the distal distance Sdesired for operation of the stretch valve. For example, the distancecan be up to 1 mm, up to 2 mm, up to 3 mm and up to even 1 or 2 cm. Thedistance S can also be dependent on the amount of stretch at theproximal end of the catheter as the displacement of the stretch-valvetube is proportional to the stretch of the catheter. For example, if thecatheter is 500 mm long and is pulled 20%, then it will be 600 mm long(a 100 mm stretch). A 10 mm or longer stretch-valve tube made from astiff material, such as metal (e.g., stainless steel, titanium, etc.)polycarbonate, polyimide, polyamide, polyurethane (Shore 55D-75D), andthe like, located near the balloon of the catheter has its proximal endglued to the inside of the inflation or drainage lumen. When thiscatheter is stretched than 20%, then the distal tip of a 10 mm stretchvalve will move 2 mm in the proximal direction. Accordingly, if thedrainage port(s) is placed 2 mm proximal to the distal end of thestretch-valve tube (here, S=2 mm), it will remain sealed by thestretch-valve tube at a stretch of about 20%. But, when the catheter ispulled slightly more than 20% (or 2 mm), the drainage port will unsealand the inflation fluid within the balloon will discharge out thedrainage port. As catheters vary among manufacturers, calibration of thepercent stretch to the force required to stretch the catheter can bedone for each different type of catheter. This force is defined inengineering terms as a modulus of the catheter and is a function of themodulus of the material and the effective wall thickness of thecatheter. Low modulus materials and catheters will stretch more thanhigh modulus materials and catheters when exposed to the same force.Exemplary catheters are those made from latex rubber or silicone rubber.Silicone rubber generally has a higher modulus than latex and,therefore, more force is required to stretch the catheter sufficientlyto discharge the pressure within the balloon. Those of skill in the art,therefore, will understand that different stretch valves lengths canprovided to dump the balloon pressure as a function of a tug-force onthe different catheters made from the different materials and havingdifferent wall thicknesses. Accordingly, even though the stretch-valvetube distances are given, they are exemplary and can change fordifferent catheters having different materials/thicknesses. As such,these exemplary distances for actuating the stretch-valve tube appliesto all embodiments described herein but are not limited thereto.

If fixation through-holes 3732, 3832 exist and are within the inflationexpanse of the balloon sleeve (not illustrated), then an adhesive can beused within the fixation through-holes 3732, 3832 to fix the proximalend of the stretch-valve tube 3730, 3830 thereat before attachment ofthe balloon sleeve. If the fixation through-holes 3732, 3832 are withinthe expanse of the balloon sleeve but only overlap at the fixed proximalend of the balloon sleeve (not illustrated), then the same adhesive thatfixes the proximal end of the balloon sleeve can be used within thefixation through-holes 3732, 3832 to fix the proximal end of thestretch-valve tube 3730, 3830 thereat in Step 4126. Finally, if thefixation through-holes 3732, 3832 are outside the expanse of the balloonsleeve proximally (not illustrated), then an adhesive or the samematerial that creates the outer wall 3740, 3840 (see below) can be usedwithin the fixation through-holes 3732, 3832 to fix the proximal end ofthe stretch-valve tube 3730, 3830.

In Step 4122, the balloon sleeve is placed about the inflation port3724, 3824 and, if present, fixation through-holes 3732, 3832 and theballoon sleeve is fixed to the exterior of the inner and inflation lumenwalls 3710, 3720, 3810, 3820 at both ends to define a fluid-tightballoon interior therebetween. As such, inflation of the balloon 3742,3842 can occur through the inflation lumen 3722, 3822. For example, theballoon sleeve making up the inner wall of the balloon 3742, 3842 isslid over the distal end of the dual-lumen extrusion to cover at leastthe inflation port 3724, 3824 and is fluid-tightly sealed to the innermulti-lumen extrusion at both ends of the balloon sleeve but not in theintermediate portion. The balloon sleeve can be made of latex as welland, therefore, can be secured to the latex multi-lumen extrusion in anyknown way to bond latex in a fluid-tight manner.

In Step 4124, the entire sub-assembly is covered with the outer wall3740, 3840. For example, the entire sub-assembly is dipped into latex inits liquid form to create the outer wall 3740, 3840. In the alternativeembodiment where a distal inflation lumen plug 3736, 3836 is not used,the latex can be allowed to enter at least a portion of the distal endof the inflation lumen 3722, 3822 but not so far as to block theinflation port 3724, 3824. When the latex cures, the balloon 3742, 3842is fluid tight and can only be fluidically connected to the environmentthrough the proximal-most opening of the inflation port, which isfluidically connected to the inflation lumen 3722, 3822. In thisprocess, the inner wall 3710, 3810, the inflation lumen wall 3720, 3820,the plug 3736, 3836, the balloon wall, and the outer wall 3740, 3840 areall made of the same latex material and, therefore, together form a verysecure water-tight balloon 3742, 3842. (Further exemplary embodimentsfor securing the stretch-valve tube 3730, 3830 in the catheter 3700,3800 are described below with regard to FIGS. 48 to 56 .)

In such configurations, therefore, any proximal movement of the catheter3700, 3800 at or proximal of the proximal anchor 3732, 3832 will alsomove the stretch-valve tube 3730, 3830 proximally; in other words, thedistal end of the stretch-valve tube 3730, 3830 can slide within theinflation lumen 3722, 3822 in a proximal direction.

The steps outlined above in the exemplary embodiments need not be donein the order described or illustrated. Any of these steps can occur inany order to create the catheter according to the various exemplaryembodiments.

FIGS. 42 and 43 illustrate the balloon portion of other exemplaryembodiments of the inventive catheter 4200, 4300, again with the balloon3842 in a partially inflated state. In these exemplary embodiments, mostof the features are the same as the catheter 3800 shown in FIG. 38 , aswell as in the other exemplary embodiments of the safety cathetersdescribed herein. What is different in FIGS. 42 and 43 is how thestretch valve operates and, therefore, the similar features use the samereference numerals as in FIG. 38 . Different features, however, use newreference numerals. Thus, description of the similar features is notrepeated below and is, instead, incorporated herein by reference fromthe above-mentioned exemplary embodiments.

In the catheters 4200, 4300, the annular inner lumen wall 4210, 4310defines therein a drainage lumen 4212, 4312. In this exemplaryembodiment, a hollow stretch-valve tube 3830 is disposed in the drainagelumen 4212, 4312 to not hinder drainage of the fluid to be drained(e.g., urine). While the diameter of the stretch-valve tube 3830 can beany size that accommodates substantially unhindered fluid flow throughthe drainage lumen 4212, 4312, one exemplary inner diameter of thestretch-valve tube 3830 is substantially equal to the diameter of thedrainage lumen 4212, 4312 and the outer diameter of the stretch-valvetube 3830 is just slightly larger than the diameter of the drainagelumen 4212, 4312 (e.g., the wall thickness of the tube can be between0.07 mm and 0.7 mm). (In any embodiment of the stretch-valve tubementioned herein, the outer diameter can be equal to or less than thediameter of the drainage lumen.) Another exemplary embodiment of thestretch-valve tube 3830, 4330 has one or more of the proximal and distalends thereof larger in outer diameter than an intermediate portion ofthe stretch-valve tube 3830, 4330. Thus, if one end is larger, thestretch-valve tube 3830, 4330 has a “club” shape and, if both ends arelarger, the stretch-valve tube 3830, 4330 has a “dumbbell” shape. Anexemplary configuration of a dumbbell shaped stretch-valve tube isdescribed hereinbelow.

The proximal end of the stretch-valve tube 3830 in this exemplaryembodiment is proximal of a proximal end of a deflation port 3860. Thelongitudinal length of the deflation port 3860 is not distal of thedistal end of the balloon 3842 so that the balloon 3842 can be deflated;the distal end can be anywhere between the two ends of the balloon 3842but is shown in an intermediate position in FIGS. 42 and 43 . The distalend of the stretch-valve tube 3830 is at a distance S distal of thedeflation port 3860 and selection of this distance S is dependent uponthe amount of stretch required to actuate the stretch-valve of theinventive catheter 4200, 4300 as described herein.

In the exemplary embodiments of FIGS. 38, 42 and 43 , the longitudinallength of the deflation port 3860 is shown as less than one half of thelongitudinal length of the stretch-valve tube 3830. The drainage port3860 is formed through the inner lumen wall 3810 and the stretch-valvetube 3830 is positioned to overlap at least the drainage port 3860. Inthis manner, a portion of the outer surface of the proximal end of thestretch-valve tube 3830 closes off the drainage port 3860 to preventfluid communication from the balloon 3842 to the drainage lumen 4212,4312 through the drainage port 3860. A second drainage port 3862 isprovided in the inner lumen wall 3810 aligned with the drainage port3860, and both drainage ports 3860, 3862 are aligned with the inflationport 3824. As such, when the stretch-valve tube 3830 moves proximally touncover the drainage ports 3860, 3862, inflation fluid 3802 from insidethe balloon 3842 exits from both the inflation port 3824 and thedrainage port 3860.

To secure the stretch-valve tube 3830 in the catheter 4200, 4300, aproximal anchor 4232, 4332 is disposed in the drainage lumen 4212 awayfrom the deflation ports 3860, 3862, here proximally at a distance E inFIG. 42 and at a longer distance F in FIG. 43 . The distances shown arenot the only sizes for the stretch-valve tube 3830 and can be shorter orlonger, the latter extending well into the drainage lumen 4212, 4312proximally even further than shown in FIG. 43 . The proximal anchor 3832can be any size or shape that accommodates substantially unhinderedfluid flow through the drainage lumen 4212, 4312, one exemplary innerdiameter of the hollow anchor 3832 being a tube or ring substantiallyequal to the diameter of the drainage lumen 4212 with an outer diameterjust slightly larger than the diameter of the drainage lumen 4212 (e.g.,the thickness of the tube can be between 0.07 mm and 0.7 mm). Theproximal anchor 3832 can be a barb or other mechanical fixation deviceas well, whether integral or connected to the stretch-valve tube 3830.The longitudinal length of this anchor 3832 can be as long as desiredbut enough to longitudinally fixedly secure the proximal end of thestretch-valve tube 3830 within the drainage lumen 4212 when installed inplace. The anchor 3832 in this exemplary embodiment is at the proximalend of the balloon 3842 as shown in FIG. 42 but it can be further insidethe balloon 3842 (i.e., distal with regard to FIG. 42 ) or entirelyproximal of the balloon 3842 as shown in FIG. 43 . The further proximalthat the anchor 3832 is connected within the drainage lumen 4212, 4312,the greater the distance of stretching material is disposed between theanchor 3832 and the drainage ports 3860, 3862, thereby enhancing theability of the safety catheter to stretch and activate thestretch-valve. (Further exemplary embodiments for securing thestretch-valve tube 3830, 4330 in the catheter 4200, 4300 are describedbelow with regard to FIGS. 48 to 56 .)

In such configurations, therefore, any proximal movement of the catheter4200, 4300 at or proximal to the drainage ports 3860, 3862 will alsomove the stretch-valve tube 3830 proximally; in other words, the distalend of the stretch-valve tube 3830 can slide within the drainage lumen4212 in a proximal direction. When the proximal end of the catheter4200, 4300 is pulled to a force that is no greater than just beforeinjury would occur to the bladder-urethral junction or the urethra ifthe catheter 4200, 4300 was still inflated when the force was imparted,the force will cause the distal end of the stretch-valve tube 3830 toslide proximally and translate and open the drainage ports 3860, 3862 ata deflation point, e.g., with a pulling force in a range of 1 to 15pounds. In another exemplary embodiment, the range of force required tomeet the deflation point is between 1 and 5 pounds, in particular,between 1.5 and 2 pounds.

When the deflation point of the stretch-valve tube 3830 occurs, theinterior of the balloon 3842 becomes fluidically connected directly intothe drainage lumen 4212, 4312 (which is open to the interior of thebladder 2020 and to the non-illustrated, proximal drain bag) and, due tothe fact that the bladder is relatively unpressurized as compared to theballoon 3842, all internal pressure is released from the balloon 3842 toeject the inflating fluid 3802 directly into the drainage lumen 4212,4312, thereby causing the balloon 3842 to deflate rapidly.

There exists the possibility that the distal end of stretch-valve tube3830 might not slide or will slide with friction when the proximal endof the catheter 4200, 4300 is pulled to a force that is enough to reachthe desired deflation point (and no greater than just before injurywould occur). To prevent such a situation from occurring, it isdesirable to enhance the stretchability of the inner lumen wall 4210distal of the anchor 3832 and, in particular, the extent E between thedrainage ports 3860, 3862 and the anchor 3832. Because the material ofthe catheters described herein is naturally stretchable, there arevarious ways to make the extent E stretch more than other portions ofthe catheter, in particular, the portion proximal of the anchor 3832.One way to increase the stretchability is to score the outside or insideof the material comprising the extent E with small cuts, notches,scratches, or other intentionally formed defects. Another way to makethe extent E more stretchable than at least the portion proximal of theanchor 3832 is to grind down the exterior or interior of the extent E. Afurther way to make the extent E more stretchable is to chemically treatthe material comprising the extent E. Yet another way to make the extentE more stretchable is to treat the material comprising the extent E witha local change in temperature, such as heating the extent E.

An altogether different way is to use different materials in thecatheter 4200, 4300. In one exemplary embodiment, at least a portion ofthe extent E is replaced with another elastomeric material differentfrom the remainder of the catheter, the other elastomeric material beingmore elastic than at least the portion of the catheter proximal of theanchor 3832. In another exemplary embodiment, the portion proximal ofthe anchor 3832 is made of an elastomeric material that is less elasticthan the extent E.

FIG. 43 shows the stretch-valve tube 4330 significantly longer than theother stretch-valve tubes and attached by the anchor 4332 to the innerlumen wall 4310 even further proximally than the other stretch-valvetubes. By making the stretch-valve tube 4330 longer, the extent E can beincreased, thereby making stretch of the portion just distal of theanchor 3832 easier and insuring activation of the stretch valve. Any ofthe exemplary embodiments of the stretch-valve tube can have a differentlength than illustrated and/or described. Combining this increase ordecrease in length of the stretch-valve tube with a decrease in theouter diameter of the stretch-valve tube can allow for tailoring thestretch-valve tube to various stretch release forces as described belowwith regard to FIG. 49 .

Even though the exemplary embodiments 4200, 4300 are shown herein withreference to FIG. 38 , they are not limited thereto and can be appliedto each of the other exemplary embodiments described herein as well.Further, the stretch enhancement feature can be added to the outer wallinstead of or in addition to the inner lumen wall. If the stretchenhancement 4270, 4370 is included in the production of any of theherein-mentioned catheters, then another manufacturing step will beneeded. As such, a stretch-enhancement creation step will be added, forexample, in the flow chart of FIG. 39 anywhere after step 3910, in theflow chart of FIG. 40 anywhere after step 4010, and in the flow chart ofFIG. 41 anywhere after step 4110.

Alternative exemplary embodiments combine various features of theembodiments described herein. For example, FIGS. 44 to 47 illustrateother exemplary embodiments of the stretch-valve tubes mentioned above.Where some features are mentioned already, similar reference numeralsare used and the descriptions thereof are not repeated.

With regard to FIGS. 44 and 45 , in contrast to a solid tube, thestretch-valve tube 4430 of the inventive catheter 4500 has a proximaltubular section 4432, a distal tubular section 4434, and an intermediateconnector 4436. As before, FIG. 45 illustrates a balloon portion of theinventive catheter 4500 with a balloon 3842 in a partially inflatedstate. An annular inner lumen wall 3810 defines therein a drainage lumen3812. At one or more circumferential longitudinal extents about theinner lumen wall 3810, an inflation lumen wall 3820 defines an inflationlumen 3822 and a balloon inflation port 3824 fluidically connected tothe inflation lumen 3822; in the inventive catheter 4500, there can bemore than one inflation lumen 3822 and corresponding inflation port 3824even though only one is shown herein. A lumen plug 3836 fluidicallycloses the inflation lumen 3822 distal of the inflation port 3824 sothat all inflation fluid 3802 is directed into the balloon 3842. Thelumen plug 3736 can plug any point or extent from the inflation port3724 distally. An outer wall 3840 covers all of the interior walls 3810and 3820 in a fluid-tight manner and forms the exterior of the balloon3842 but does not cover the distal end of the drainage lumen 3812. Theouter wall 3840 is formed in any way described herein and is notdiscussed in further detail here.

In this exemplary embodiment, the stretch-valve tube 4430 is disposed inthe drainage lumen 3812 to not hinder drainage of the fluid to bedrained (e.g., urine). While the diameter of the stretch-valve tube 4430can be any size that accommodates substantially unhindered fluid flowthrough the drainage lumen 3812, one exemplary inner diameter of thestretch-valve tube 4430 is substantially equal to the diameter of thedrainage lumen 3812 and the outer diameter of the stretch-valve tube4430 is just slightly larger than the diameter of the drainage lumen3812 (e.g., the wall thickness of the tube can be between 0.07 mm and0.7 mm). The proximal tubular section 4432 of the stretch-valve tube4430 in this exemplary embodiment is proximal of a proximal end of thedeflation port 3860. The distal tubular section 4434 of thestretch-valve tube 4430 is not distal of the distal end of the balloon3842 so that the balloon 3842 can be deflated; the distal end can beanywhere between the two ends of the balloon 3842 but is shown in anintermediate position in FIG. 45 . The distal tubular section 4434 ofthe stretch-valve tube 4430 covers the deflation port 3860longitudinally in the steady-state or unactuated state of the valve. Theoverlap distance S distal of the deflation port 3860 is dependent uponthe amount of stretch required to actuate the stretch-valve of theinventive catheter 4500 as described below.

To secure the stretch-valve tube 4430 in the catheter 4500, a proximalanchor 3832 is disposed in the drainage lumen 3810 away from thedeflation ports 3860, 3862, here proximally. The proximal anchor 3832can be any size or shape that accommodates substantially unhinderedfluid flow through the drainage lumen 3812, one exemplary inner diameterof the hollow anchor 3832 being a tube or ring substantially equal tothe diameter of the drainage lumen 3812 with an outer diameter justslightly larger than the diameter of the drainage lumen 3812 (e.g., thethickness of the tube can be between 0.07 mm and 0.7 mm). The proximalanchor 3832 can be a barb or other mechanical fixation device as well,whether integral or connected to the stretch-valve tube 4430. Thelongitudinal length of this hollow anchor 3832 can be as long as desiredbut just enough to longitudinally fixedly secure the stretch-valve tube4430 within the drainage lumen 3812 when installed in place. The anchor3832 in this exemplary embodiment is at the proximal end of the balloon3842 but can be further inside the balloon 3842 (distal) or entirelyproximal of the balloon 3842 as shown. In an exemplary embodiment, theanchor 3832 has a stepped distal orifice that permits the proximal endof the stretch-valve tube 4430 to be, for example, press-fit therein forpermanent connection. In another exemplary embodiment, the anchor 3832is an adhesive or glue that fixes the proximal end of the stretch-valvetube 4430 longitudinally in place within the drainage lumen 3812. Theadhesive can be the same material as any or all of the walls 3810, 3820,3840 or it can be a different material. In an exemplary non-illustratedembodiment where a fixation port or set of fixation ports are formedthrough the inner wall 3810 proximal of the proximal-most end of theballoon 3842 and about the proximal end of the stretch-valve tube 4430,if the outer wall 3840 is formed by a dipping of the interior parts intoa liquid bath of the same material as, for example, a dual lumenextrusion including the inner wall 3810 and the inflation lumen wall3820, then, when set, the outer wall 3840 will be integral to both theinner wall 3810 and the inflation lumen wall 3820 and will be fixedlyconnected to the stretch-valve tube 3820 through the fixation port(s).(Further exemplary embodiments for securing the stretch-valve tube 4430in the catheter 4500 are described below with regard to FIGS. 48 to 56.)

In such a configuration, therefore, any proximal movement of thecatheter 4500 at or proximal to the deflation ports 3860, 3862 will alsomove the stretch-valve tube 4430 proximally; in other words, the distalend of the stretch-valve tube 4430 can slide within the drainage lumen3812 in a proximal direction. When the proximal end of the catheter 4500is pulled to a force that is no greater than just before injury wouldoccur to the bladder-urethral junction or the urethra if the catheter4500 was still inflated when the force was imparted, the force willcause the stretch-valve tube 4430 to slide proximally to place thedistal end of the stretch-valve tube 4430 just proximal of the deflationports 3860, 3862, e.g., with a pulling force in a range of 1 to 15pounds. In another exemplary embodiment, the range of force required tomeet the deflation point is between 1 and 5 pounds, in particular,between 1.5 and 2 pounds.

When the deflation point of the stretch-valve tube 4430 occurs, theinterior of the balloon 3842 becomes fluidically connected directly intothe drainage lumen 3812 (which is open to the interior of the bladder2020 and to the non-illustrated, proximal drain bag) and, due to thefact that the bladder is relatively unpressurized as compared to theballoon 3842, all internal pressure is released from the balloon 3842 toeject the inflating fluid 3802 directly into the drainage lumen 3812,thereby causing the balloon 3842 to deflate rapidly. Because there is nointermediate structure between the balloon inflating fluid 3802 and thedrainage lumen 3812, the rate at which the balloon 3842 deflates isfast. One way to speed up deflation can be to shape the deflation ports3860, 3862 in the form of a funnel outwardly expanding in a directionfrom the outer wall 3840 towards the interior of the catheter 3800.Another way to speed up deflation can be to have two or more deflationports 3860 about the circumference of the inner lumen wall 3810 and/orto enlarge the cross-sectional area of the deflation ports 3860, 3862.

The intermediate portion 4436 is not solid and is, instead, either asmall tubular arc section (shown) or even multiple arc sections (notillustrated) or can be merely a line connecting the two tubular portions4432, 4434 together (not illustrated). As such, the stretch-valve tube4430 defines an intermediate flex gap. In such a configuration, if madefrom the same material as the other stretch-valve tubes describedherein, the stretch-valve tube 4430 has increased flexibility due to thedecrease in material used. If made of a material that has lessflexibility, then the shortened proximal and distal portions 4432, 4434combined with the narrow intermediate portion 4436 allows thestretch-valve tube 4430 to be sufficiently flexible to not hinderinsertion of the catheter 4500. Further, insertion of the stretch-valvetube 4430 into the drainage lumen is similar.

With regard to FIGS. 46 and 47 , also in contrast to a solid tube, thestretch-valve assembly 4730 of the inventive catheter 4700 has aproximal coil section 4632, a distal plug 4634, and a distal coilsection 4436. As before, FIG. 47 illustrates a balloon portion of theinventive catheter 4700 with a balloon 3842 in a partially inflatedstate. An annular inner lumen wall 3810 defines therein a drainage lumen3812. At one or more circumferential longitudinal extents about theinner lumen wall 3810, an inflation lumen wall 3820 defines an inflationlumen 3822 and a balloon inflation port 3824 fluidically connected tothe inflation lumen 3822; in the inventive catheter 4700, there can bemore than one inflation lumen 3822 and corresponding inflation port 3824even though only one is shown herein. A lumen plug 3836 fluidicallycloses the inflation lumen 3822 distal of the inflation port 3824 sothat all inflation fluid 3802 is directed into the balloon 3842. Thelumen plug 3736 can plug any point or extent from the inflation port3724 distally. An outer wall 3840 covers all of the interior walls 3810and 3820 in a fluid-tight manner and forms the exterior of the balloon3842 but does not cover the distal end of the drainage lumen 3812. Theouter wall 3840 is formed in any way described herein and is notdiscussed in further detail here.

In this exemplary embodiment, the stretch-valve assembly 4630 isdisposed in the drainage lumen 3812 to not hinder drainage of the fluidto be drained (e.g., urine). The proximal coil section 4632 has a largerdiameter than the intermediate coil section 4636 because the proximalcoil section 4632 acts as the device to secure the stretch-valveassembly 4630 inside the drainage lumen 3812 and the intermediate coilsection 4636 acts as the measures by which the distal plug 4634 is movedout and away from the deflation port 3860, 3862. The intermediate coilsection 4636 can have a pitch with looser coils to permit bending of thecatheter body without kinking. While the diameter of the proximal coilsection 4632 can be any size that accommodates substantially unhinderedfluid flow through the drainage lumen 3812, one exemplary outer diameterof the rest- or steady-state of the proximal coil portion 4632 is justslightly larger than the diameter of the drainage lumen 3812 (e.g., thewall thickness of the tube can be between 0.07 mm and 0.7 mm). Incomparison, one exemplary outer diameter of the rest- or steady-state ofthe intermediate coil section 4636 is just slightly smaller than thediameter of the drainage lumen 3812. In this manner, proximal movementof the secured proximal coil section 4632 pulls upon the intermediatecoil section 4636 to cause the distal plug 4634 to slide out andproximally away from the deflation port 3860, 3862. One exemplaryconfiguration of the distal plug 4634 is a heat shrunk polyolefinattached to the coil with cyanoacrylate.

The proximal coil section 4632 of the stretch-valve assembly 4630 inthis exemplary embodiment is proximal of a proximal end of the deflationport 3860, 3862. The distal plug 4634 of the stretch-valve assembly 4630is not distal of the distal end of the balloon 3842 so that the balloon3842 can be deflated; the distal plug 4634 can be anywhere between thetwo ends of the balloon 3842 but is shown in an intermediate position inFIG. 47 . The distal plug 4634 of the stretch-valve assembly 4630 coversthe deflation ports 3860, 3862 longitudinally in the steady-state orunactuated state of the valve. An overlap distance distal of thedeflation ports 3860, 3862 is dependent upon the amount of stretchrequired to actuate the stretch-valve of the inventive catheter 4700 asdescribed below.

To secure the stretch-valve assembly 4630 in the catheter 4700, noproximal anchor is needed in addition to the stretch-valve assembly4630. Here, the proximal anchor is the proximal coil section 4632,which, when allowed to expand to its native diameter, self-secures inthe drainage lumen 3812 and accommodates substantially unhindered fluidflow through the drainage lumen 3812. The longitudinal length of theproximal coil section 4632 can be as long as desired but just enough tolongitudinally fixedly secure the stretch-valve assembly 4630 within thedrainage lumen 3812 when installed in place. The anchor 4632 in thisexemplary embodiment is proximal of the proximal end of the balloon 3842but can be further inside the balloon 3842 (distal) or even furtherproximal of the balloon 3842 than shown. In another exemplaryembodiment, an adhesive or glue can fix the proximal coil section 4632of the stretch-valve assembly 4630 longitudinally in place within thedrainage lumen 3812. The adhesive can be the same material as any or allof the walls 3810, 3820, 3840 or it can be a different material. In anexemplary non-illustrated embodiment where a fixation port or set offixation ports are formed through the inner wall 3810 proximal of theproximal-most end of the balloon 3842 and about the proximal coilsection 4632 of the stretch-valve assembly 4630, if the outer wall 3840is formed by a dipping of the interior parts into a liquid bath of thesame material as, for example, a dual lumen extrusion including theinner wall 3810 and the inflation lumen wall 3820, then, when set, theouter wall 3840 will be integral to both the inner wall 3810 and theinflation lumen wall 3820 and will be fixedly connected to the proximalcoil section 4632 through the fixation port(s).

In such a configuration, therefore, any proximal movement of thecatheter 4700 at or proximal to the drainage ports 3860, 3862 will alsomove the stretch-valve assembly 4630 proximally; in other words, thedistal plug 4634 of the stretch-valve assembly 4630 can slide within thedrainage lumen 3812 in a proximal direction. When the proximal end ofthe catheter 4700 is pulled to a force that is no greater than justbefore injury would occur to the bladder-urethral junction or theurethra if the catheter 4700 was still inflated when the force wasimparted, the force will cause the distal plug 4634 to slide proximallyto open the drainage ports 3860, 3862, e.g., with a pulling force in arange of 1 to 15 pounds. In another exemplary embodiment, the range offorce required to meet the deflation point is between 1 and 5 pounds, inparticular, between 1.5 and 2 pounds.

One exemplary method for installing the stretch-valve assembly 4630 inthe drainage lumen 3812 is to turn down the coil of the proximal coilsection 4632 temporarily on a mandrel that has a diameter equal to orsmaller than the inner diameter of the intermediate coil section 4636and hold it in place. Then, the contracted proximal coil section 4632 isinserted into the drainage lumen 3812 to the implantation or securingpoint. The, contracted proximal coil section 4632 is allowed to expand,thereby securing proximal portion of the stretch-valve assembly 4630 inthe drainage lumen 3812 with the intermediate coil section 4636 anddistal plug 4634 movably disposed therein.

The proximal and intermediate coil sections 4632, 4636 can be made of asingle coil that is wound with two different diameters and/or twodifferent pitches.

As set forth above, many of the exemplary catheters described herein canconnect the stretch-valve tube merely by the shape of the tube itself.This connection is described with reference to FIG. 48 , whichillustrates a configuration of a catheter 4800 having features thatapplicable to each of the exemplary catheters described herein. Thus,the “48” prefix will be used for illustration purposes. In each of thecatheters, an annular inner lumen wall 4810 defines therein a drainagelumen 4812 and an inflation lumen wall 4820 defines an inflation lumen4822 and a non-illustrated balloon inflation port fluidically connectedto the inflation lumen 4822. An outer wall 4840 covers all of theinterior walls 4810 and 4820 in a fluid-tight manner and forms theexterior of the balloon 4842. A hollow, stretch-valve tube 4830 isdisposed in the drainage lumen 4812 to not hinder drainage of the fluidto be drained (e.g., urine). While the diameter of the stretch-valvetube 4830 can be any size that accommodates substantially unhinderedfluid flow through the drainage lumen 4812, the exemplary outerdiameters of the stretch-valve tube 4830 allow the distal end of thestretch-valve tube 4830 to slide within the drainage lumen 4812 when thevalve is activated. One exemplary size of the stretch-valve tube 4830has one or more of the proximal and distal ends thereof larger in outerdiameter than an intermediate portion of the stretch-valve tube 4830.Thus, if one end is larger, the stretch-valve tube 2830 has a “club”shape and, if both ends are larger, the stretch-valve tube 4830 has a“dumbbell” shape. An exemplary configuration of a dumbbell shapedstretch-valve tube is described hereinbelow.

In the various embodiments of catheters described herein, one end of thestretch-valve tube is indicated as being “fixed” in the respectivecatheter, while the opposite end is slidably disposed therein. Someexemplary embodiments described for fixing this end include adhesives(such as cyanoacrylate) and structures, and some describe the fixationas being fixed solely from its shape alone. As used herein, therefore,the measures for “fixation” do not need to be a separate material or aseparate device. Accordingly, some exemplary embodiments can providefixation of the stretch-valve tube simply by inserting the stretch-valvetube within the respective lumen. More specifically, one consequence ofstretching the flexible catheter (for example, when a urinary catheteris prematurely pulled out) is that the stretched portion collapsesradially inwards towards the longitudinal axis as the catheter bodylengthens. There are two common examples of explaining this behavior:the Poisson Effect and the Chinese finger trap.

The Poisson effect is a negative ratio of transverse to axial strain.When a sample object is stretched (or squeezed), to an extension (orcontraction) in the direction of the applied load, it corresponds to acontraction (or extension) in a direction perpendicular to the appliedload. More specific to the invention herein, when the catheter is pulledrelative to its ends, the catheter contracts in diameter andcircumference. Therefore if a more rigid tube (the stretch valve) isplaced in the lumen of a less rigid tube (the catheter), the diameter ofthe catheter decreases as it is extended axially and hugs the stretchvalve. If the distal balloon on the catheter is held in place by thebladder-urethral junction and the proximal end of the catheter is pulledaxially, as the catheter diameter contracts, it hugs the stretch valveand pulls the stretch valve proximally to the extent that it releasesfluid from the balloon into at least one of the lumens in the catheter.This hugging is more pronounced on the proximal end (the right end inFIG. 48 than on the distal end). As such, the proximal end of thestretch-valve tube is squeezed while the distal end of the stretch-valvetube moves proximally to open the safety valve.

Another way to explain this effect is with the Chinese finger trap, alsoknown as a Chinese finger puzzle or Chinese handcuffs (a gag toy used toplay a practical joke). The finger trap is a simple puzzle that snaresthe victim's fingers (often the index fingers) in both ends of a small,woven bamboo cylinder. The initial reaction of the victim is to pull thefingers outward (i.e., stretching the tube), but this only tightens thetrap. The way to escape the trap is to push the ends toward the middle,which enlarges the circumference of the two end openings and frees thefingers. The tightening is simply a normal behavior of a cylindrical,helically wound braid, usually the common biaxial braid. Pulling theentire braid from its ends lengthens and narrows it. The length isgained by reducing the angle between the warp and weft threads at theircrossing points, but this reduces the radial distance between opposingsides and hence the overall circumference.

The stretch-valve described herein takes advantage of the Poisson andChinese Puzzle Effects by extending the stretch-valve tube 4830sufficiently proximal so that the proximal end resides within the areaof stretching. This distance need not be far towards the proximal end ofthe catheter and can even reside in the proximal end of the balloon4842. However, it has been found that a short distance, such as a fewmillimeters to a few centimeters is all that is needed to position theproximal end in the area of stretching. As such, when the balloon 4842is held stationary (e.g., in the bladder) and the proximal end of thecatheter is pulled (e.g., by a patient), the reduction in circumferenceof the drainage lumen 4812 automatically increases the inward graspingforce on the proximal end of the stretch-valve tube 4830 but does notplace the same inward force against the distal end of the stretch-valvetube 4830 covering the drainage port (not illustrated in FIG. 48 ). Thiseffect is illustrated in the enlarged FIG. 48 (which is not drawn toscale) where the distal portion of the stretch-valve tube 4830 shown (tothe left) does not touch the interior wall of the drainage lumen 4812but the proximal end of the stretch-valve tube 4830 (to the right) issqueezed by the interior wall of the drainage lumen 4812. Simply put, asthe proximal end of the catheter 4800 is pulled away from the balloon4842, the center portion 4850 of the catheter 4800 being stretcheddecreases in circumference C′ and grips the proximal end of thestretch-valve tube 4830 while the unstretched or less-stretched portion4860 substantially retains its circumference C, thereby allowing thedistal end of the stretch-valve tube 4830 to slide and actuate thestretch valve of the present invention.

In this embodiment, therefore, all of the fixation through-holes 2150,2450, 2750, 3732, 3832 describe above become unnecessary and lead to avery simple configuration for manufacturing. Not only the shape itselfcan provide the fixation as described, properties of the stretch-valvetube and the material comprising the lumen in which the stretch-valvetube resides can provide the fixation as well. For example, if thematerial of the stretch-valve tube 4830 is selected such that itslightly grips the interior of the drainage lumen 4812 (or vice versa),then the gripping of the proximal end of the stretch-valve tube 4830 canbe increased.

In some of the various embodiments of catheters described herein, thestretch-valve tubes have been shown as smooth cylinders. Alternativeexemplary embodiments of these stretch-valve tubes do not require aconstant outer diameter. The ability to tailor release of thestretch-valve can be enhanced when the stretch-valve tube 4900 haseither or both of the proximal 4910 and distal 4920 ends of thestretch-valve tube 4900 larger in outer diameter than an intermediateportion 4930 of the stretch-valve tube 4900. In such a configuration, ifone end is larger, the stretch-valve tube has a “club” shape (notillustrated) and, if both ends are larger (as shown in FIG. 49 ), thestretch-valve tube 4900 has a “dumbbell” shape.

The proximal 4910 and distal 4920 ends of the stretch-valve tube 4900can be equal in outer diameter 4912, 4922 or they can have differentouter diameters. In an exemplary embodiment, the outer surface of thedistal end 4920 is smooth to seal against the deflation port(s). Theouter surface of the proximal end 4910 can be smooth or rough or havefastening devices (such as barbs, extensions, adhesives). In anexemplary embodiment the outer diameter 4912 of the proximal end 4910 isslightly larger than the outer diameter 4922 of the distal end 4920. Theoverall length of the stretch-valve tube 4900 is between 1.5″ and 3″ orlonger.

The following is an exemplary embodiment of a stretch valve tube 4900where the inner diameter of the lumen in which the stretch-valve tube4900 is to be placed (e.g., drain lumen of a Foley catheter) is 0.1″ andthe balloon of the catheter has a length of 1.0″ with the ballooninflation hole and the drainage port located in the center of theballoon. For such a configuration, the approximate dimensions for thestretch valve made from a polyurethane tube of Shore 95A with a wallthickness of between approximately 0.004″ and approximately 0.012″, inparticular, between approximately 0.006″ and approximately 0.009″, areas set forth in the following text.

The length of the proximal end 4912 is between approximately 0.1″ andapproximately 0.5″, in particular, approximately 0.25″. The outerdiameter 4914 of the proximal end 4910 is between approximately 0.1″ to0.15″, in particular, approximately 0.110″. The length of the distal end4922 is between approximately 0.1″ and approximately 0.5″, inparticular, approximately 0.25″. The outer diameter 4924 of the distalend 4920 is between approximately 0.1″ to 0.15″, in particular,approximately 0.108″. The length 4932 of the intermediate portion 4930is between approximately 0.5″ and approximately 3″ or longer, inparticular, approximately 2″. The outer diameter 4934 of theintermediate portion 4930 is between approximately 0.1″ to 0.09″, inparticular, approximately 0.095″.

It is noted that the length 4914 of the proximal end does not need to bethe same as the length 4924 of the distal end and, in particular, it canbe longer. Further, where the diameter measurement is normalized to 0.1″as above, the outer diameter 4914 of the proximal end 4910 is 10% largerand the outer diameter 4924 of the distal end 4920 is 8% larger. Theinner diameter of the proximal 4920, intermediate 4930, and proximal4910 portions can be the same or different (as shown. The wallthickness, too, can vary throughout if desired. For example, where thetube is an extrusion and the intermediate portion 4930 is made smallerby stretching, the wall will be reduced where it is stretched.

The drainage port of the balloon is located somewhere along the length4922 of the distal end 4920, anywhere from the center of the length 4922to 25% on either side thereof and, in particular, within the proximal75% of the length 4922. If desired, the area opposing the drainageportion on the length 4922 can have raised boss to have a form-fit intothe port.

If the stretch-valve tube is made by extrusion, it can be modified on amold after it is extruded.

Other alternative exemplary embodiments of the stretch-valve tubesdescribed herein do not require either a constant outer diameter or aconnecting intermediate tube. Some of such exemplary embodiments havebeen described with regard to FIGS. 35, 36, and 44 to 47 . The exemplaryembodiment shown and described with regard to FIG. 36 has a string, rod,cord, or other linear, small diameter structure. Likewise, the exemplaryembodiment shown and described with regard to FIG. 44 has a string, rod,cord, or other linear, small diameter structure connecting two tubularsegments 4432, 4434. Still another exemplary embodiment of a stretchvalve 5000 is shown in FIGS. 50 to 52 . This stretch valve 5000 has aproximal cylindrical base 5010 and a distal cylindrical sliding plug5020. Connecting the base 5000 and the plug 5020 is a connector 5030that can be of any material with a higher modulus than the materialcomprising the catheter, for example, a monofilament or multi-strandedthread made of metal (stainless steel, titanium, Nitinol, cobaltchromium, and the like) or a polymer made from polyester terephthalate(PET), fluoropolymer (PTFE, polyvinylidene fluoride, etc.),polycarbonate, polyurethane, nylon, polyimide, polyamide, cellulose,polysulphone, or polyolefin (polyethylene, polypropylene, etc.). Thematerial can also be a compound material, for example, a stretchablemonofilament (e.g., Lycra® or spandex) braided or wound with a PETthread or the like, such as those stretchable filaments found onunderwear or brassieres. One requirement is that, at some point when thecatheter is stretched, the connector becomes taut and pulls the slidableplug from the drainage hole.

The base 5120 has a connection area 5012 that attaches the connector5030 thereto. In this exemplary embodiment, the connection area 5012 isa slot projecting from a proximal edge of the base 5000 distally and theproximal end of the connector 5030 has an enlarged area 5032 that, whenthe connector 5030 is threaded into the slot 5012, the enlarged area5032 rests on an outer surface of the base 5010 and, due to its size, itcannot pull through the slot. Furthermore, when the base 5010 is fixedin the proximal area 5112 of the drain lumen 5110, the enlarged area5032 is trapped and thereby fixed in the drain lumen 5110 along with thebase 5010. Likewise, the sliding plug 5020 has a connection area 5112that connects the connector 5030 thereto. Here, the connection area 5112is a slot projecting from a distal edge of the sliding plug 5000proximally and the distal end of the connector 5030 has an enlarged area5034 (such as a knot) that, when the connector 5030 is threaded into theslot 5112, the enlarged area 5034 rests on an outer surface of thesliding plug 5020. As such, when the sliding plug 5020 is slidablydisposed in the area 5114 of the drain lumen 5110 within the balloon5120 to plug the drainage ports 5116, the enlarged area 5034 is trappedand thereby sandwiched between the sliding plug 5020 and the surface ofthe drain lumen 5110 along with the sliding plug 5020. The connectionareas 5012, 5112 being a slot and the enlarged area 5214 being, forexample, a knot in the cord of the connector 5030 is merely oneexemplary configuration of the structure for connecting the variousrespective parts to one another. Other examples include pin-holes wherethe connector is inserted through the pin hole and a knot is formed onthe other side of the pin-hole to prevent the connector from pullingaway from the pin-hole. Alternatively, instead of a knot, an adhesivecan be used to fasten the connector to the plug or base.

FIG. 51 illustrates the stretch valve 5000 installed inside the drainlumen 5110 of the catheter 5100, for example, the drain lumen of aurinary catheter. In this illustration, the balloon 5120 is slightlyinflated and the plug 5020 covers, i.e., plugs, the drainage ports 5116,which can be at the inflation lumen 5118 and opposite the inflationlumen 5118 as shown, or there can be additional ports around thecircumference of the drain lumen 5110 within the interior extent of theballoon 5120. The connector 5030 is sized to be at least as long orlonger than the longitudinal distance between the base 5010 fixed in thedrain lumen 5112 and the plug 5020 when it plugs the drainage ports5116. In such a configuration, the plug 5020 will remain in place tokeep the balloon 5120 inflated until the catheter 5100 is stretched pastthe extent in which the connector 5030 becomes taut. With addedstretching, therefore, the plug 5020 is pulled proximally (to the rightin FIGS. 50 to 52 ) as the proximal end of the catheter 5100 (the rightend of the catheter 5100 in FIGS. 50 to 52 ) is stretched further, aswhat occurs when a patient pulls the catheter 5100 in an attempt toremove it or when the drainage bag or line becomes tangled with theenvironment and the patient moves or falls. After the connector 5030becomes taut and the plug 5020 starts to move proximally, the drainageports 5116 are unplugged, thereby allowing the inflation fluid insidethe balloon 5120 to drain into the drain lumen 5110 and prevent injuryto a patient.

FIG. 52 illustrates a different situation than when the catheter 5100 ispulled by the patient or is tangled with the environment. In thesituation of FIG. 52 , the catheter 5100 is within a lumen 5200 of thepatient, for example, a urethra, which is indicated with the dashedlines. The balloon 5120 is traversed within the urethra 5200 but not tothe bladder 5210. In this situation, the balloon 5120 should not beinflated. Nonetheless, the person installing the catheter 5100 attemptsto inflate the balloon 5120, which, if successful, would causesignificant damage to the patient. As set forth above, the existence ofthe stretch valve provides the ability to control and eliminateinflation when the balloon 5120 is constricted. When the balloon 5120 isattempted to be inflated within the confines of a urethra, instead ofstretching mostly in the radial direction, the small urethra causes theballoon to mostly stretch in the longitudinal direction—the samedirection as the actuation axis of the stretch valve. Such a stretchedstate is shown in FIG. 52 and causes the stretch valve to open, bystretching open one or both of the deflation ports past one end of theplug 5020, prior to causing significant damage to the lumen and,thereby, directing the inflation fluid into the drain lumen 5110 insteadof the balloon 5120 as indicated with the dashed arrows. In thissituation, the balloon 5120 does not expand radially to cause any or asmuch damage as would be caused in a prior art urinary catheter.

In order to provide the above safety functionality, the plug 5020 has alongitudinal length that is between approximately 10% and approximately100% greater on each side of the drainage ports 5116. In other words, inan example where the drainage port is 0.4 inches long, the plug 5020 hasa length of between approximately 0.48″ and 1.2″ long. In particular,the plug 5020 has a longitudinal length that is between approximately10% and approximately 40% greater on each side of the drainage ports5116 or between approximately 15% and approximately 25% greater on eachside of the drainage ports 5116.

Still another exemplary embodiment of a stretch valve 5300 is shown inFIGS. 53 to 55 . This stretch valve 5300 has a proximal cylindrical base5310 and a distal cylindrical sliding plug 5320. Connecting the base5300 and the plug 5320 is an at least partially elastic connector 5330that can be of any material, for example, a monofilament ormulti-stranded thread made of metal (stainless steel, titanium, Nitinol,cobalt chromium, and the like) or a polymer made from polyesterterephthalate (PET), fluoropolymer (PTFE, polyvinylidene fluoride,etc.), polycarbonate, polyurethane, nylon, polyimide, polyamide,cellulose, polysulphone, polyolefin (polyethylene, polypropylene, etc.).The material can also be a compound material, for example, a stretchablemonofilament (e.g., Lycra® or spandex) braided or wound with a PETthread or the like, such as those stretchable filaments found onunderwear or brassieres.

The connector 5330 can be inelastic at a first portion and elastic at asecond portion or there can be a number of inelastic and elasticportions along the entire extent. In the exemplary embodiment shown inFIGS. 53 and 54 , a proximal portion 5332 is inelastic and a distalportion 5335 is elastic and is in the form of a spring. The spring canbe made of metal using spring-forming equipment well-known in the art.The spring can also be made from polymer that is heat-formed in ahelical configuration.

The base 5300 has a connection area 5312 that attaches the connector5330 thereto. In this exemplary embodiment, the connection area 5312 isa hole adjacent a proximal edge of the base 5300 and the proximal end ofthe connector 5330 has a hook 5332 that, when the connector 5030 ishooked into the hole 5312, the hook 5332 extends into the center of thebase 5310. As such, when the base 5310 is fixed in the proximal area5312 of the drain lumen 5410, the hook 5332 is trapped and thereby fixedin the drain lumen 5410 along with the base 5310. Likewise, the slidingplug 5320 has a connection area 5312 that connects the connector 5330thereto. Here, the connection area 5312 is a hole adjacent a distal edgeof the plug 5320 and the distal end of the connector 5330 has a hook5334 that, when the connector 5330 is hooked into the hole 5312, thehook 5334 ends within the center of the sliding plug 5320. As such, whenthe sliding plug 5320 is slidably disposed in the area 5314 of the drainlumen 5410 within the balloon 5420 to plug the drainage ports 5416, thehook 5334 is trapped and thereby sandwiched between the sliding plug5320 and the surface of the drain lumen 5410 along with the sliding plug5320.

FIG. 54 illustrates the stretch valve 5300 installed inside the drainlumen 5410 of the catheter 5400, for example, the drain lumen of aurinary catheter. In this illustration, the balloon 5420 is slightlyinflated and the plug 5320 covers, i.e., plugs, the drainage ports 5416,which can be at the inflation lumen 5418 and opposite the inflationlumen 5418 as shown, or there can be additional ports around thecircumference of the drain lumen 5410 within the interior extent of theballoon 5420. The connector 5330 is sized to be substantially equal tothe longitudinal distance between the base 5310 fixed in the drain lumen5512 and the plug 5320 when it plugs the drainage ports 5416 without anysubstantial elastic stretching of the elastic portion 5334. In such aconfiguration, the plug 5320 will remain in place to keep the balloon5420 inflated until the catheter 5400 is stretched to, thereby stretchthe elastic portion past the extent in which the plug 5320 starts toslide. With this sliding, the plug 5320 moves proximally (to the rightin FIGS. 53 and 54 ) as the proximal end of the catheter 5400 (the rightend of the catheter 5400 in FIGS. 53 and 54 ) is stretched further, aswhat occurs when a patient pulls the catheter 5400 in an attempt toremove it or when the drainage bag or line becomes tangled with theenvironment and the patient moves or falls. After the elastic portion5334 stretches and the plug 5320 starts to move proximally, the drainageports 5416 become unplugged, thereby allowing the inflation fluid insidethe balloon 5420 to drain into the drain lumen 5410 and prevent injuryto a patient.

FIG. 54 shows an alternative exemplary embodiment of the connectionareas and connection parts of the connector 5300. In this embodiment,the connection area 5412 is a slot projecting from a proximal edge ofthe base 5300 distally and the proximal end of the connector 5330 has anenlarged area 5432 (such as a knot) that, when the connector 5330 isthreaded into the slot 5412, the enlarged area 5432 rests on an outersurface of the base 5310. As such, when the base 5310 is fixed in theproximal area 5412 of the drain lumen 5410, the enlarged area 5432 istrapped and thereby fixed in the drain lumen 5410 along with the base5010. Likewise, the sliding plug 5320 has a connection area 5414 thatconnects the connector 5330 thereto. Here, the connection area 5414 is aslot projecting from a distal edge of the sliding plug 5320 proximallyand the distal end of the connector 5330 has an enlarged area 5434 that,when the connector 5330 is threaded into the slot 5414, the enlargedarea 5434 rests on an outer surface of the sliding plug 5320. As such,when the sliding plug 5320 is slidably disposed in the area of the drainlumen 5410 within the balloon 5420 to plug the drainage ports 5416, theenlarged area 5434 is trapped and thereby sandwiched between the slidingplug 5320 and the surface of the drain lumen 5410 along with the slidingplug 5320. The connection areas 5312, 5412, 5314, 5414 being a hole/hookor a slot/enlarged area are merely example of a structure for connectingthe various respective parts to one another.

FIG. 54 illustrates an unactuated state of the stretch valve in thecatheter 5400 such that, when the catheter 5400 is pulled by the patientor is tangled with the environment, the plug 5320 will move proximallyaway from the drainage ports 5416 and unplug them to allow the ballooninflation fluid to immediately drain into the drain lumen 5410.

FIGS. 53 and 55 show an alternative embodiment of the plug 5020, 5320 inwhich the plug 5020, 5320 is provided with a detent, a boss, or anotherextending structure that extends away from the outer surface of thesliding plug 5020, 5320 to resist movement out from the drainage ports5116, 5416 as well as to help seal the drainage hole. Here, the plug5020, 5320 is provided with two spherical portions or nubs 5500 onopposing sides to align with the two opposing drainage ports 5116, 5416(as before, two in number is merely exemplary). These portions 5500provide increased resistance to sliding of the plug 5020, 5320 andincrease alignment of the stretch valve 5000, 5300 with respect to thecatheter 5100, 5400 and increased sealing of the drainage hole. AlthoughFIG. 55 shows a plug with two holes, the same can be accomplished withonly one hole providing that there is only one transverse drainage holeto be sealed.

In the exemplary embodiments of FIGS. 50 to 55 , the connector 5030,5330 is shown as extending through the drain lumen 5110, 5410. Theconnector 5030, 5330 can also extend through the inflation lumen 5118,5418 as well. One advantage of placing the stretch valve in theinflation lumen is that only inflation fluid (e.g., saline) is typicallywithin the inflation lumen, which is not exposed to contamination fromthe bladder or urine. Another advantage of placing the stretch valve inthe inflation lumen is that there is no narrowing of the drainage lumen.When urinary catheters are inserted, some patients develop small clotsfrom the balloon rubbing against the bladder lining. Such clots cansometimes occlude the drain lumen even without a stretch valve. Therealso exists the possibility of calcium encrustation from the urine. Afurther advantage of placing the stretch valve in the inflation lumen isthat such encrustation will not occur. One disadvantage of placing thestretch valve in the inflation is that it is smaller and, therefore,more difficult to function in a smaller diameter. However, the inflationlumen can be made larger to facilitate placement of the stretch-valve.

In an alternate exemplary embodiment shown in FIG. 56 , the plug 5620can be a simple cork-like structure connected to the connector 5630. Inthis embodiment, the catheter 5640 has only one drainage port 5642. Thebase 5610 is fixed to the connector 5630 and is fixed to the interiorwall 5614 of the drain lumen 5644, e.g., adjacent the proximal end ofthe catheter 5640. The plug 5620 also is fixed to the connector 5630 andis shaped to plug up the drainage port 5646. As such, when the plug 5620is installed within the balloon 5650, it plugs the drainage port 5646.

FIG. 56 illustrates the stretch valve 5600 installed inside the drainlumen 5644 of the catheter 5640, for example, the drain lumen of aurinary catheter. In this illustration, the balloon 5650 is slightlyinflated and the plug 5620 plugs the drainage port 5646, which can beanywhere about the drain lumen 5644 and even at the inflation lumen5418; FIG. 57 shows the plug 5620 and the base 5610 in the inflationlumen 5418 and FIG. 58 shows the plug 5620 and the base 5610 in thedrain lumen 5644. There can be additional drainage ports 5646 around thecircumference of the drain lumen 5644 within the interior extent of theballoon 5650 each closed by another plug 5620 connected to the connector5630. The connector 5630 is sized to be at least as long or longer thanthe longitudinal distance between the base 5010 fixed in the drain lumen5644 and the plug 5620 when it plugs the drainage port 5646. In such aconfiguration, the plug 5620 will remain in place to keep the balloon5650 inflated until the catheter 5640 is stretched past the extent inwhich the connector 5630 becomes taut. With added stretching, therefore,the plug 5620 is pulled proximally (to the right in FIG. 56 ) as theproximal end of the catheter 5640 (the right end) is stretched further,as what occurs when a patient pulls the catheter 5640 in an attempt toremove it or when the drainage bag or line becomes tangled with theenvironment and the patient moves or falls. After the connector 5630becomes taut and the plug 5620 starts to move proximally, the drainageport 5646 is unplugged, thereby allowing the inflation fluid inside theballoon 5650 to drain into the drain lumen 5644 and prevent injury to apatient.

One exemplary embodiment of a plug 5020, 5320 has a longitudinal lengthof 0.25″, an inner diameter of 0.09″, and an outer diameter of 0.1″. Thenubs 5500 can be 0.005″ high and have a base diameter 0.06″ and can beproduced, for example, by injection molding of the plug in a mold,wherein the nubs are formed in the mold with a ball mill.

In the exemplary embodiments of FIG. 56 , the connector 5630 is shown asextending through the drain lumen 5644. The connector 5630 can alsoextend through the inflation lumen 5418 as well. In such aconfiguration, the plug 5620, when pulled proximally, will exit thedrainage port 5646 and be pulled into the inflation lumen 5418. As theplug 5620 is much larger in size than the cross-section of the inflationlumen 5418, and due to the fact that the walls of the inflation lumen5418 are flexible, the plug 5620 will become stuck within the inflationlumen 5418 and prevent re-inflation of the balloon 5650.

Each of the stretch-valve embodiments of FIGS. 21 to 38 and 42 to 56also affords another significant benefit. The presence of thestretch-valve provides a way to self-regulate the balloon so that it isable to deflate automatically when over-inflated, a characteristic thatis not present in the prior art. More specifically, when the balloon isoverinflated, the stretch valve actuates to release the excessivepressure into the drain lumen. When the balloon is inflated to itsintended size with the pre-defined amount of inflation fluid, theballoon expands without stretching any portion of the multi-lumeninterior or the catheter material proximal of or distal to the balloon.However, when the balloon is over-inflated, this excessive inflationforces the ends of the balloon (i.e., the distal and proximal poles ofthe circular balloon) attached to the catheter to move away from eachother. As this movement occurs, the drainage hole elongates to a pointwhere it is longer than the stretch valve or becomes misaligned with thestretch valve, which actuates release of fluid from the balloon into thedrainage lumen of the catheter. If the balloon is over-inflatedsufficiently to actuate the stretch valve, the resulting movementautomatically deflates the balloon until the proximal and distal ends ofthe balloon no longer stretch the catheter portions surrounding theballoon. When the ends of the balloon are no longer stretched, thestretch valve closes, thereby stopping deflation mid-stream andretaining the balloon in its intended inflation size.

In an exemplary embodiment of the safety urinary catheter, the stretchvalve has the stretched state when the length between the proximal endof the catheter and the proximal balloon end is elongated betweenapproximately 5 percent and approximately 200 percent, in particular,between approximately 5 percent and approximately 75 percent.Alternatively, or additionally, the stretch valve has the stretchedstate when the length between the ends of the balloon is elongatedbetween approximately 5 percent and approximately 200 percent, inparticular, between approximately 5 percent and approximately 75percent.

The existence of the stretch valve also provides a further benefit—theability to control and eliminate inflation when the balloon isconstricted. It is known that inflation of a balloon in a lumen that ismuch smaller than the intended destination is a common occurrence (e.g.,when the balloon of a catheter is attempted to be inflated within theconfines of a urethra instead of the bladder) and leads to serious anddebilitating patient injuries. Prior art catheters are unable to preventinflation when constricted in a small lumen. In contrast, the stretchvalve configurations described herein are able to prevent inflation whenconstricted in a small lumen. As described above, in addition tostretching in the radial direction, the balloon also stretches in thelongitudinal direction—the same direction as the actuation axis of thestretch valve. When constricted in a lumen, the balloon is not permittedto stretch radially but is permitted to stretch longitudinally. Thisstretching causes the stretch valve to open prior to causing significantdamage to the lumen in which the balloon is being inflated (e.g., theurethra), thereby directing the inflation fluid into the drain lumeninstead of the balloon. In the particular embodiment of a urinarydrainage catheter, the stretch valve opens before injury is caused tothe lumen of the urethra.

In each of the embodiments where a stretch valve exists, actuation ofthe stretch valve within the patient can be indicated visually to a useror a health professional—a situation that is not able to be provided byprior art balloon catheters. As described above, atechnician/physician/user inserting a balloon catheter does not knowwhere the balloon is placed within the body after the balloon isinserted therein unless some type of costly radiographic or sonographicequipment is used. With the inventive safety catheters described herein,however, the inflation fluid has the opportunity to exit the balloonand, when it does, it provides a unique and automatic way of informingthe user or health-care professional that a dangerous condition has justbeen prevented and additional attention is desirable. More specifically,if the inflation fluid contains an inert colorant that is different fromany color of fluid that typically is drained by the balloon catheter,the herein-described safety catheters will show, visually andimmediately, either that an attempt has been made to inflate the balloonwithin a constricted lumen (such as the urethra) or that the catheterhas been stretched enough to cause the stretch-valve of the insertedballoon to act and prevent possible pull-out injury. Almost immediatelyafter triggering, the colored inflation fluid enters the fluid drainagebag. When anyone sees this colored fluid, he/she knows that the balloonis not correctly placed and corrective action needs to be takenimmediately before injury or further injury occurs. Although the abovedescribes a colored inflation fluid, the catheter can be provided with apowder dye dispersed in the deflated lumen of the device. When inflationmedia contacts and solubilizes the dye, the inflation media turns thecolor of the dye which, if released from the stretch valve as theballoon inflates, alerts the inserter of improper placement or inflationof the balloon. Placing the powder dye in the lumen allows the inserterto use conventional inflation media such as sterile saline.

In most of the embodiments described herein, reference is made to aurinary drainage catheter. As set forth herein, this is merely one goodexemplary embodiment for describing the inventive safety featuresoutlined herein. Specifically, the inventive features are not limited toa urinary drainage catheter; they can be applied to various and numerouscatheter devices that probe various other areas of the anatomy and areused in other clinical situations.

In a first alternative exemplary embodiment, the self-regulating andself-deflating balloon can be used with coronary sinus catheterinsertion. A coronary sinus catheter is a flexible device with a balloonat its end to be placed in the coronary sinus vein in the back of heart.It is used to deliver retrograde cardioplegia solution to arrest theheart for open heart surgery. In the prior art, if the balloon is overlydistended, the vessel (CS) may rupture or bleed excessively, causinggreat harm to the patient or death. The stretch valve can be included inthe coronary sinus catheter to limit the amount of inflation of thatballoon, thereby preventing distension of the coronary sinus.

In a second alternative exemplary embodiment, the self-regulating andself-deflating balloon can be used with airway breathing tubes (such asendotracheal tubes and tracheostomy tubes). These devices are usedcommonly in medical care to provide assistance with breathing. After thetrachea has been intubated, a balloon cuff of these devices is typicallyinflated just above the far end of the tube to help secure it in place,to prevent leakage of respiratory gases, and to protect thetracheobronchial tree from receiving undesirable material such asstomach acid. The tube is then secured to the face or neck and connectedto a T-piece, anesthesia breathing circuit, bag valve mask device, or amechanical ventilator. Over-distention of the balloon cuff can causetrauma and damage to the lining of the airway over time. This is socritical that medical personnel attempt to check the pressure of theballoon cuff at the time of first inflation and often thereafter. Butgases may diffuse into or out from the balloons over time or too muchair can be placed in the balloon inadvertently. The stretch valve can beincluded in these airway breathing tubes to limit the amount ofinflation of that balloon, thereby preventing distension of the trachea.

In a third alternative exemplary embodiment, the self-regulating andself-deflating balloon can be used with thrombus removal devices, forexample, Fogarty-type, atherectomy balloon catheters. These cathetersare used to pull thrombi out of arteries. Accordingly, if the balloon ofsuch catheters is over-inflated or over-pressurized (i.e., when theballoon is inflated in a compressed state such as in a lumen that issmaller than the balloon diameter), it can cause damage to the arterialwall, resulting in stenosis. The stretch valve can be included in thesethrombus removal devices to limit the amount of inflation of thatballoon, thereby preventing damage to arterial walls. Other Fogarty-typeballoons are used to dilate strictures such as arterial venous fistulaused for dialysis. These fistulas commonly stricture. In use, theFogarty-type balloon is advanced proximal to the stricture and theballoon is inflated. The inflated balloon then is rapidly withdrawnacross the stricture, which then opens the stricture by fracturing thefibrous bands. However it is not uncommon for the balloon to rupture andleave a foreign body in the lumen, which then would require an emergencyoperation. A balloon that self-deflates when experiencing such highpressures such as one including the stretch valve would prevent thisfrom happening. Balloons are used to dilate strictures in almost anyvessel in the body. Examples include, but are not limited to, stricturesin the common bile duct, pancreatic duct, intestinal strictures often atanastomotic sites, lacrimal ducts, and parotid ducts. These vessels areoften very delicate and can be damaged with over inflation. Stricturesalso occur in the urethra, in the ureter, in the esophagus, and in thegastrointestinal tract. In each case, over-inflation of the balloon cancause a burst that may injury the structure in which it is being used.Combining the stretch valve described herein with such balloons wouldprevent this complication from happening.

In a fourth alternative exemplary embodiment, the self-regulating andself-deflating balloon can be used with balloon isolation catheters,which are used to block the flow of blood, for example, while drugs areinjected on either side of the blockage. Over-distension of the ballooncan cause damage to the vessel in which the isolation catheter isinflated. The stretch valve can be included in these balloon isolationcatheters to limit the amount of inflation of that balloon, therebypreventing damage to lumen walls.

In a fifth alternative exemplary embodiment, the self-regulating andself-deflating balloon can be used with angioplasty balloon catheters,in particular, those comprised of flexible balloons including Nylon 12.Over-inflation of the balloon in such catheters can lead to rupture ofthe artery, which can be catastrophic to the patient. The stretch valvecan be included in these angioplasty balloon catheters to limit theamount of inflation of that balloon, thereby preventing damage to lumenwalls.

In a sixth alternative exemplary embodiment, the self-regulating andself-deflating balloon can be used with valvuloplasty catheters. Suchcatheters are used to break calcium deposits in heart valves.Over-distention can damage cells in the annulus of the valve, which canlead to inflammation and scar tissue formation. The stretch valve can beincluded in these valvuloplasty catheters to limit the amount ofinflation of that balloon, thereby preventing damage to the annulus.

In a seventh alternative exemplary embodiment, the self-regulating andself-deflating balloon can be used with vertebroplasty balloons. Ifballoons for vertebroplasty are over-distended, they can cause rupturingof the vertebra. A release mechanism will render this procedure safer.The stretch valve is such a release mechanism for inclusion in avertebroplasty device.

In an eighth alternative exemplary embodiment, the self-regulating andself-deflating balloon can be used with tamponade procedures. Oneexample is during bronchoscopy when a biopsy is taken. After such aprocedure, bleeding may occur. A balloon is passed over the bleed andinflated to compress the bleeding vessel. However, over-inflation inthis delicate organ can easily cause ischemic damage. The stretch valvedisclosed herein can be used with the tamponade balloon to prevent anyinjury from happening.

The various catheters 200, 300, 1000, 1600, 2100, 2400, 2700, 3300,3400, 3500, 3600, 3700, 3800, 4200, 4300, 4500, 4700, 4800, 4900, 5100,5400, 5640 described herein mention the catheter stretching from itsproximal end when pulled. This movement can be described equally andcorrespondingly as a longitudinal movement of one of the ends of theballoon relative to the other of the ends of the balloon or, likewise,can be described as a longitudinal movement of one of the ends of theballoon away from the other of the ends of the balloon.

The catheters 200, 300, 1000, 1600, 2100, 2400, 2700, 3300, 3400, 3500,3600, 3700, 3800, 4200, 4300, 4500, 4700, 4800, 4900, 5100, 5400, 5640according to the invention can be used in vascular applications. It isknown that every vessel has a tearing pressure. Balloons are used incoronary arteries, for example. If a coronary artery balloon were toburst, there would be less damage if the burst was controlled accordingto the invention. The same is true for a renal or iliac blood vessel. Insuch situations, the breakaway catheter improves upon existing cathetersby making them safer. From the urinary standpoint, the breakaway balloonwill not only prevent injury, but will also be a signal to thetechnician that he/she needs to obtain the assistance of a physician orurologist with respect to inserting the catheter.

1. A method of manufacturing a safety catheter, which comprises:providing a catheter comprising: a catheter body comprising an exteriorsurface; a drainage lumen; and an inflation lumen; forming a ballooninflation port between the exterior surface and the inflation lumen;forming a deflation port between the exterior surface and one of theinflation lumen and the drainage lumen; fixing a balloon sleeve to theexterior surface of the catheter over at least the balloon inflationport to define a fluid-tight balloon interior between an interiorsurface of the balloon sleeve and at least a portion of the exteriorsurface of the catheter body; removably inserting a deflation plug inthe deflation port to water-tightly seal the deflation port until thedeflation plug is removed; connecting a proximal portion of a deflationconnector to an inside surface of one of the inflation lumen and thedrainage lumen; and connecting a distal portion of the deflationconnector to the deflation plug.
 2. The method according to claim 1,which further comprises forming the deflation port to connectfluidically the interior of the balloon to the interior of the one ofthe inflation lumen and the drainage lumen.
 3. The method according toclaim 1, wherein the inflation lumen comprises a distal end and whichfurther comprises forming the deflation port between the exteriorsurface and the distal end of the inflation lumen.
 4. The methodaccording to claim 3, which further comprises removably inserting thedeflation plug in the deflation port.
 5. The method according to claim3, which further comprises forming the deflation port by forming thedeflation plug therein simultaneously with the creation of the catheterbody.
 6. The method according to claim 1, wherein the inflation lumencomprises a distal end and which further comprises forming the deflationport at the distal end of the inflation lumen.
 7. The method accordingto claim 1, which further comprises forming the deflation port in adistal portion of the inflation lumen.
 8. The method according to claim1, which further comprises forming the deflation port at a distalportion of the drainage lumen.
 9. The method according to claim 1, whichfurther comprises fixing the balloon sleeve to the exterior surface ofthe catheter over at least the balloon inflation port and the deflationport.
 10. The method according to claim 1, which further comprisesproviding the catheter by extruding the catheter body defining theinterior drainage and inflation lumens.
 11. The method according toclaim 10, which further comprises extruding the catheter body from atleast one of latex and silicone.
 12. The method according to claim 1,which further comprises simultaneously forming the deflation port andthe balloon inflation port.
 13. The method according to claim 1, whichfurther comprises forming the deflation port between the exteriorsurface and both the inflation lumen and the drainage lumen.
 14. Themethod according to claim 1, wherein the deflation port is one of:proximal of the balloon inflation port; and distal of the ballooninflation port.
 15. The method according to claim 1, wherein thedeflation port is aligned longitudinally with the balloon inflationport.
 16. The method according to claim 1, wherein the drainage portfluidically connects: the interior of the balloon to the interior of thedrainage lumen; and the interior of the inflation lumen to the interiorof the drainage lumen.
 17. The method according to claim 1, whichfurther comprises carrying out the balloon sleeve fixing step by fixingthe balloon sleeve to surround a longitudinal distal portion of thecatheter.
 18. The method according to claim 1, which further comprisescarrying out the deflation connector connecting step by connecting adistal portion of the deflation connector to the deflation plug throughat least a portion of the drainage lumen.
 19. The method according toclaim 1, which further comprises carrying out the fixing step by:sliding the balloon sleeve over a distal end of the dual-lumen catheterbody to cover the inflation port and the drainage port; andfluid-tightly sealing both ends of the balloon sleeve to the exteriorsurface of the catheter.
 20. The method according to claim 1, whereinthe balloon sleeve and the catheter are of the same material.